Lichterfeld Kottner2019

International Journal of Nursing Studies 103 (2020) 103509
Contents lists available at ScienceDirect
International Journal of Nursing Studies

journal homepage: www.elsevier.com/ijns
Maintaining skin integrity in the aged: A systematic review

A. Lichterfeld-Kottner a,∗, M. El Genedy b, N. Lahmann a, U. Blume-Peytavi b, A. Büscher c,
J. Kottner b,d
a
Geriatrics Research Group, Nursing Research Group, Charité-Universitätsmedizin Berlin, Reinickendorfer Str. 61, 13347 Berlin, Germany
b
Department of Dermatology and Allergy, Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117
Berlin, Germany
c
German Network for Quality Development in Nursing (DNQP), University of Applied Sciences, Osnabrück, Germany
d
Department of Public Health, Ghent University, University Centre for Nursing and Midwifery, De Pintelaan 185, 9000 Gent, Belgium
article info abstract
Article history: Background: In aged nursing care receivers, the prevalence of adverse skin conditions such as xerosis cutis,
Received 15 April 2019 intertrigo, pressure ulcers or skin tears is high. Adequate skin care strategies are an effective method for
Received in revised form 11 September 2019
maintaining and enhancing skin health and integrity in this population.
Accepted 16 December 2019
Objectives: The objective was to summarize the empirical evidence about the effects and effectiveness
of non-drug topical skin care interventions to promote and to maintain skin integrity and skin barrier
Keywords:
function in the aged, to identify outcome domains and outcome measurement instruments in this field.
Cosmetics
Hospital Design: An update of a previous systematic review published in 2013 was conducted.
Long-term care Data sources: Databases MEDLINE and EMBASE via OvidSP and CINAHL (original search January 1990 to
Nursing August 2012, update September 2012 to May 2018) and reference lists were searched. Forward searches
Skin in Web of Science were conducted.
Skin care Methods: A review protocol was registered in Prospero (CRD42018100792). Main inclusion criteria were
Skin cleansing primary intervention studies reporting treatment effects of basic skin care strategies in aged people with
Prevention a lower limit of age range of 50 years and published between 1990 and 2018. Primary empirical stud-
ies were included with experimental study designs including randomized controlled trials and quasi-
experimental designs. Methodological quality of included randomized controlled trials was evaluated us-
ing the Cochrane Collaboration’s Tool for assessing risk of bias. Levels of evidence were assigned to all
included studies.
Results: Sixty-three articles were included in the final analysis reporting effects of interventions to treat
and/or to prevent skin dryness, pruritus, general skin barrier improvement, incontinence-associated der-
matitis, skin tears and pressure ulcers. Skin cleansers containing syndets or amphotheric surfactants
compared with standard soap and water improved skin dryness. Lipophilic leave-on products containing
humectants decreased skin dryness and reduced pruritus. Products with pH 4 improved the skin barrier.
Application of skin protectants and structured skin care protocols decreased the severity of incontinence-
associated dermatitis. Formulations containing glycerin and petrolatum reduced the incidence of skin
tears. Thirty-five outcome domains were identified with nearly 100 different outcome measurement in-
struments.
Conclusion: Included studies showed substantial heterogeneity regarding design, interventions and out-
comes. Basic skin care strategies including low-irritating cleansers and lipophilic humectant-containing
leave-on products are helpful for treating dry skin and improving skin barrier in the aged. Lower pH of
leave-on products improves the skin barrier. The number of different outcome domains was unexpectedly
high. We recommend to identify critical outcome domains in the field of skin care to make trial results
more comparable in the future and to measure possible performance differences between different skin
care strategies and products.
© 2020 Elsevier Ltd. All rights reserved.
What is already known about the topic?
∗
• Aging skin undergoes structural and functional changes.
Corresponding author.
• Xerosis cutis, pressure ulcers and skin tears are frequent in
E-mail address: andrea.lichterfeld@charite.de (A. Lichterfeld-Kottner).
aged care.
https://doi.org/10.1016/j.ijnurstu.2019.103509
0020-7489/© 2020 Elsevier Ltd. All rights reserved.
2 A. Lichterfeld-Kottner, M. El Genedy and N. Lahmann et al. / International Journal of Nursing Studies 103 (2020) 103509
• Leave-on products containing humectants reduce symptoms of skin barrier function in the aged. Another aim was to identify re-
skin dryness. ported outcome domains and outcome measurement instruments
in the field of preventive skin care in the aged.
What this paper adds
2. Methods
• Regular application of leave-on products reduces signs of dry
skin and prevents skin tears.
This is an update of the systematic review published in 2013
• A lower pH of leave-on products improves skin barrier integrity.
(Kottner et al., 2013) using similar methods. The protocol was pre-
• Standardized skin care approaches including skin protectants
viously registered in the Prospero database (CRD42018100792).
prevent incontinence-associated dermatitis.
1. Introduction 2.1. Eligibility criteria
The aging population is growing worldwide. The proportion of Studies had to meet identical inclusion criteria as those in the
the worldś population aged over 60 years will increase to 22% previous systematic review (Kottner et al., 2013). Primary empir-
until 2050. These demographic changes present challenges to all ical studies were included with experimental study designs com-
health care systems and care settings worldwide. Age dependent prising randomized controlled trials (RCTs) and quasi-experimental
morphological and functional changes affect the whole body, but designs including before after studies describing, analyzing and re-
also the skin (Blume-Peytavi et al., 2016). For example, the skin porting treatment effects of basic skin care strategies. This included
barrier function declines and immunological processes are reduced skin cleansing procedures and/or use of rinse-off and/or use of
(Al-Nuaimi et al., 2014). The content of natural moisturizing fac- leave-on products used for promoting and maintaining of skin in-
tors and lipids in the stratum corneum is decreased. Reduced wa- tegrity in the aged. Examples include cosmetic products such as
ter content in the stratum corneum causes impaired enzymatic moisturizers, soaps, syndets, and emulsions or medical devices.
processes leading to dry skin (Toncic et al., 2018). Xerosis cutis is Further inclusion criteria were: humans; in vivo studies; physio-
one of the most common dermatological diagnosis in the elderly. logically aged skin including xerosis; publication dates September
The prevalence ranges from 30% to 100% in different care settings 2012 to May 2018; languages: English, German; lower limit of age
(Hahnel et al., 2017a, 2017b, 2017c, Paul et al., 2011; White-Chu range 50 years.
and Reddy, 2011). Epidermal and dermal thinning and increased Exclusion criteria were: age <50 years; non-research papers,
cutaneous stiffness leads to a higher risk for shear-type injuries e.g., narrative reviews, editorials, letters to the editor; tool de-
such as skin tears or pressure ulcers. The prevalence of these skin velopment and/or validation studies; observational studies with-
conditions in aged persons over 60 years ranges from 4% to 30% out interventions; studies focusing on the treatment of diseased
(Hahnel et al., 2017a, 2017b, 2017c, LeBlanc et al., 2016; Toncic skin like rosacea, atopic dermatitis. Studies including diseased and
et al., 2018). Against this background, adequate skin care strategies non-diseased subjects were included when the proportion of dis-
are an effective method for maintaining and enhancing skin health eased patients was under 25%. Medicinal product studies; anti-
and integrity in the aged (Lichterfeld et al., 2015). aging treatments to improve skin appearance of photo damaged
Maintaining and improving skin health are integral parts of skin and in vitro studies were excluded as well. Conference ab-
nursing practice; therefore, skin integrity serves as a quality indi- stracts were included in the first systematic review of 2013 due
cator in nursing care (Nakrem et al., 2009). Patients and residents to the lack of evidence, but excluded in this update.
in acute and long-term care settings receive daily routine skin care
delivered by nurses, including washing, bathing, and showering, to-
2.2. Information sources and search
gether with the application of lotions, creams, and/or ointments
(Kottner et al., 2015; Lechner et al., 2018; Rahn et al., 2016). Al-
The databases MEDLINE and EMBASE via OvidSP (first search
though these personal hygiene and skin care activities are daily
from 1990 to August 2012, update from September 2012 to May
activities of nursing practice, little is known about their benefits
2018) were searched. The database CINAHL was searched using EB-
or clinical efficacy.
SCOhost (first search from 1990 to August 2012, update September
A systematic review published in 2013 (Kottner et al., 2013) re-
2012 to May 2018) using a comparable search strategy (Table 1).
vealed, that the empirical evidence supporting preventive skin care
Reference lists of included possible eligible articles were screened
strategies in the aged is rare and of high risk of bias. The main
for additional studies. After inclusion of studies from database
conclusions were that the use of low-irritating cleansing products
searches and reference lists a forward search was conducted in
and humectant- or occlusive-containing leave-on products seem to
Scopus (October 2018) for identification of additional relevant
have beneficial effects compared to using standard soap and water
studies citing already included studies.
or no treatment. A major limitation of this evidence summary was
the non-comparability of study outcomes.
The problem of outcome heterogeneity in clinical trials is con- 2.3. Study selection and data collection process
sidered today as one major challenge in evidence based health-
care in general and skin research specifically (Kottner et al., 2018; Results of the database searches were screened independently
Kottner and Schmitt, 2018; Schmitt et al., 2018). Today, several by two reviewers (AL, MG) based on title and abstract. Possible rel-
initiatives exist for developing so called core outcome sets, that evant articles were read in full text by the two reviewers (AL, MG)
might be one solution to standardize outcome measurement and independently. A third reviewer (JK) resolved possible discrepan-
reporting in clinical trials. A core outcome set consists of outcome cies. Structured data extraction tables were prepared and struc-
domains and outcome measurement instruments (Prinsen et al., tured summary data extraction tables were completed including
2014). source, study design, setting, sample and indication, intervention,
The aim of this work was to update the existing systematic re- study duration, number of included subjects, mean age, outcomes,
view (Kottner et al., 2013) and to summarize the empirical evi- main results and methodological appraisal. Results of individual
dence about the effects and effectiveness of non-drug topical skin studies were extracted from the text, recalculated if necessary and
care interventions to promote and to maintain skin integrity and summarized in data extraction sheets.
A. Lichterfeld-Kottner, M. El Genedy and N. Lahmann et al. / International Journal of Nursing Studies 103 (2020) 103509 3
Table 1 study identification process, screening and eligibility. One hundred

Search strategy in the databases Medline and Embase using OVID 1990–2018.
eighty-eight articles were read in full-text in the original review
Search terms Original Search #Total and 100 articles in the update. Sixty-three articles were finally in-
review update cluded in the quantitative data analysis (33 articles in the original
2013
review and 30 articles in the update). Seventy articles were ex-
1. Emollien∗ .ti. or emollien∗ .ab. or 5666 3963 9629 cluded in the update and are listed as online Appendix 1 including
“Emollients” reasons for exclusion.
2. Moisturi∗ .af. 2848 5576 8424
3. Skin care product∗ .af. 828 1498 2326
4. Skin care/ – 13,998 13,998
5. Skin/an, ah, cl, di [Analysis, – 7313 7313 3.2. Study characteristics and risk of bias
Anatomy & Histology,
Classification, Diagnosis]
Included studies are summarized in Tables 2 to 5 describing
6. hygiene/ – 57,540 57,540
7. 1 or 2 or 3 or 4 or 5 or 6 87,007 87,007 the study designs, indications, interventions, sample characteris-
8. Limit 7 to (“middle aged (45 plus 4,234,597 60,264 4.294861 tics, outcomes, risk of bias, and Levels of Evidence. A detailed de-
years)” or “all aged (65 and scription of all included studies is presented in online Appendix 2.
over)” or “aged (80 and over)”) Some included articles reported more than one study (Quatresooz
9. Limit 8 to (clinical trial or – 3534 3534
randomized controlled trial or
et al., 2009; Weber et al., 2012; Angelova-Fischer et al., 2018; Behm
controlled clinical trial or et al., 2015). Of the total of 63 included studies, 31 studies ad-
multicenter study) dressed prevention and treatment of dry skin, 12 studies were re-
10. Limit 9 to human 26,293,275 3399 26,296,674 lated to skin barrier improvement, 13 to incontinence-associated
11. Limit 10 to yr = “2012–Current” – 1325 1325
dermatitis prevention, 6 to pressure ulcer and 5 to skin tear pre-
12 Limit 11 to yr = “1990–2012” 732 – 732
13. Remove duplicates from 11 to 12 690 1166 1856 vention.
Of the 31 studies reporting prevention or treatment of skin
dryness, 15 studies were included in the original systematic review
(Kottner et al., 2013) and the update includes 16 studies (Blaak
2.4. Risk of bias in individual studies
et al., 2017; Chang et al., 2018; Cristaudo et al., 2015; Danby et al.,
2016; Federici et al., 2012; Federici et al., 2015; Gillis et al., 2016;
The risk of bias of the included RCTs was evaluated by the
Gin et al., 2017; Hahnel et al., 2017a, 2017b, 2017c, Izumi et al.,
Cochrane Collaboration’s Tool for assessing risk of bias (Higgins,
2017; Korponyai et al., 2017; Martini et al., 2017; Weber et al.,
2008). The tool includes six possible bias categories: sequence
2012) (Table 2). In total, 1657 subjects participated in these studies.
generation, allocation concealment, blinding, incomplete outcome
Further ten articles were included reporting 12 studies
data, selective outcome reporting and other potential threats to va-
(Angelova-Fischer et al., 2018; Behm et al., 2015; Blaak et al.,
lidity. These categories were judged as “low risk of bias”, “high risk
2015; Brooks et al., 2017; Farwick et al., 2014; Narbutt et al., 2016;
of bias”, or “unclear”. The Cochrane Collaboration’s Tool for assess-
Paulela et al., 2018; Schoonhoven et al., 2015; Elewa et al., 2012;
ing risk of bias was developed for assessing risk of bias for ran-
Roure et al., 2012) for maintaining and improvement of skin barrier
domized trials. Therefore, we only appraised the included RCTs us-
integrity (Table 3). The included studies for dry skin prevention
ing this tool. Risk of bias of the quasi-experimental studies was not
and treatment comprised 21 RCTs. The highest Level of Evidence of
evaluated.
2 was assigned to six RCTs (Federici et al., 2015; Hahnel et al., 2017,
A Level of Evidence ranging from 1 to 5 was assigned based
2017b, 2017c, Martini et al., 2017; Pham et al., 2002; Quatresoz
on the Oxford Center for Evidence Based Medicine framework.
et al. 20 09a, 20 09b). Due to quasi-experimental designs and high
Level of Evidence 1 indicates evidence based on systematic re-
risk of bias 10 studies had Level of Evidence of 3. Intra-individual
views of RCTs. RCTs or observational studies with a dramatic ef-
comparisons were used for six RCTs and group comparisons
fect were categorized to Level of Evidence 2, non-randomized con-
in 15.
trolled cohort/follow-up studies were assigned to Level of Evidence
Studies for skin barrier improvement included six RCTs with a
3, Level of Evidence 4 based on case-control studies, and Level of
Level of Evidence of 3 and six studies with quasi-experimental de-
Evidence 5 based on mechanism-based reasoning. If there were
sign. Of these, four studies had a Level of Evidence of 3 (Brooks
methodological limitations or high risk of bias the Level of Evi-
et al., 2017; Elewa et al., 2012; Farwick et al., 2014; Narbut et al.
dence was graded down. RCTs in this review were downgraded if
2016), and two studies had a Level of Evidence of 4 (Behm et al.,
more than four quality criteria were not met. The Level of Evidence
2015, Roure et al., 2012). Two RCTs used intra-individual compar-
can be interpreted as an overall indicator for study design, quality
isons and in four RCTs group comparisons were used.
and therefore the internal validity of the study results.
The original review included 9 studies addressing incontinence-
associated dermatitis prevention (Beeckman et al., 2011; Bliss et al.,
2.5. Summary measures and synthesis of results 20 06, 20 07; Byers et al., 1995; Cooper et al., 2008; Cooper and
Gray 2001, Lewis-Byers and Thayer, 2002, Lyder et al., 1992,
Results are presented descriptively per identified skin condition. Warshaw et al., 2002, Zehrer et al., 2004). Four additional stud-
The skin condition categories were developed inductively based on ies were included in the update reporting incontinence-associated
the reported study outcomes. Reported outcome measurement in- dermatitis management including 1845 subjects in total (Brunner
struments were iteratively assigned to outcome domains. et al., 2012; Conley et al., 2014; Kon et al., 2017; Park and Kim,
2014) (Table 4).
3. Results Overall, 5 studies addressed skin tear prevention (Mason 1997;
Birch and Coggins 2003; Groom et al., 2010; Carville et al., 2014;
3.1. Study selection Finch et al., 2018). Interventions for pressure ulcer prevention were
investigated in six studies (Clever et al., 2002; Hunter et al., 2003;
The electronic database searches in MEDLINE, CINAHL and EM- Thompson et al., 2005; Torra i Bour et al. 2005; Lupianez-Perez
BASE resulted in 1387 records in the original review and 1465 et al., 2015; Verdu and Soldevilla, 2012) (Table 5). In total, 4121
records in the update. Fig. 1 shows the Prisma flow diagram of the subjects participated in these studies. Most of these were RCTs
Fig. 1. Prisma flow chart.
with Level of Evidence of 3 and two with Level of Evidence of 2 Papanas et al., 2011; Hahnel et al. 2017, 2017b, 2017c, Pham et al.,
(Verdu and Soldevilla, 2012; Torra i Bou et al. 2005). 2002; Schölermann et al., 1998; Weber et al., 2012) and resulted
The calculation of comparable summary measures across stud- in decreased skin dryness (Level of Evidence 2 to 3). In most
ies was not possible due to the large heterogeneity of investigated studies, skin dryness was also decreased in the comparator group
treatments and reported study outcomes. In the following sections, (Federici et al., 2012; Gin et al., 2017; Hahnel et al., 2017, 2017b;
we summarize the effects of the skin care interventions per iden- Weber et al., 2012a, Schölermann et al., 1999). Additionally, bio-
tified skin problem. physical skin parameters such as stratum corneum hydration in-
creased (Federici et al., 2015; Weber et al., 2012), or transepider-
3.3. Preventing and treating dry skin mal water loss decreased (Danby et al., 2016; Weber et al., 2012)
as signs for skin improvement and recovery (Level of Evidence
3.3.1. Application of leave-on skin care products 2 to 3).
Twenty-four (Table 2) studies evaluated effects of leave-on The same was observed when using products containing glyc-
products with or without humectants (e.g. urea, glycerol, lactate), erin in different concentrations (Behm et al., 2015; Cristaudo et al.,
different product pH or other ingredients such as panthenol. The 2015; Gin et al., 2017; Korponyai et al., 2017; Weber et al., 2012a)
application of urea with the concentrations from 5%, 10% or 40% (Level of Evidence 3) but when different formulations containing
was investigated in 10 studies (Danby et al., 2016; Federici et al., glycerol were compared, no differences were observed in terms of
2012; Federici et al., 2015; Gin et al., 2017; Kuzima et al. 2002; stratum corneum hydration (Quatresooz et al., 2009).
Table 2
Summary of included studies for prevention and treatment of dry skin.
Source Design Setting/ Sample/ Intervention Study n Mean age (years) Outcomes Main results Risk of bias
Indication duration (Intervention/ Sequence Allocation Blinding Completeness Selection Other LoE
control) generation
Blaak et al. RCT Elderly subjects, Intervention 3 weeks 23 73.5 (1) TEWL (1) Decrease in TEWL in Unclear Unclear Unclear Yes Yes Unclear 3
(2017) treatment of skin Twice daily (2) SCH intervention vs. control
dryness application of a (3) Skin pH (p = 0.003);
A. Lichterfeld-Kottner, M. El Genedy and N. Lahmann et al. / International Journal of Nursing Studies 103 (2020) 103509
plant (4) Quality of EPB (2) Increase in SCH vs. control
oil-containing (5) Lipid profile/ordering (p < 0.001),
acidic O/W (6) Number of lipids (3) Unchanged skin pH in both
emulsion adjusted groups,
to pH 4 (4) Increased quality of EPB in
Comparator/control intervention vs. control
Untreated skin (p = 0.019),
(5) Normalized lipid
profile/ordering after treatment
in intervention,
(6) Increased lipid content in
intervention vs. control
(p < 0.001)
Chang et al. Quasi-experimental Outpatients, Intervention 15 days 25 63 (1) 5-point severity scale (1) Decreased skin dryness n.a. 3
(2018) treatment of skin skin care regimen for skin dryness (baseline vs. day 15, p < 0.05);
dryness including (2) SCH (2) Increased SCH (baseline vs. day
over-the-counter (3) TEWL 15, p < 0.05);
body wash and a (4) Desquamation (3) Slight decreased TEWL (not
moisturizer (5) Severity of Pruritus significant);
containing (6) Impact of Pruritus (4) Decrease in desquamation
sunflower seed oil (7) Patient satisfaction (p < 0.05) and
panthenol, shea (8) AEs (5) severity (p < 0.05) and (6)
butter impact of pruritus (p < 0.001)
Comparator (baseline vs. day 15);
No comparator (7) Positive participant satisfaction
(8) No AEs occurred
Cristaudo et al. Quasi-experimental Healthy subjects Intervention 4 weeks 50 65 (1) Severity of xerosis Decrease of (baseline vs. week 4): n.a. 3
(2015) with dry skin, Twice daily (2) Scaling (1) Xerosis severity (p < 0.0 0 01),
treatment of skin application of a (3) Skin tightness (2) Scaling (p < 0.0 0 01),
dryness cream containing (4) Fissuring (3) Tightness (p < 0.0 0 01),
glycerol and (5) Excoriations (4) Fissuring (p < 0.0 0 01),
paraffin (6) Erythema (5) Excoriations (p < 0.0 0 01),
Comparator (7) Itching (6) Erythema (p < 0.0 0 01),
No comparator (8) TEWL (7) Itching (p < 0.0 0 01),
(9) SCH (8) TEWL (p < 0.001),
(9) Increase of SCH (p < 0.001)
Danby et al. RCT Healthy subjects Intervention 4 weeks 42 69/68 (1) TEWL (1) Slight decreased TEWL in No Unclear Unclear Unclear Yes Unclear 3
(2016) with dry skin, Emollient with 5% (2) Redness intervention (p = 0.002),
treatment of skin urea, ceramide (3) SCH increased in comparator;
dryness NP, lactate (4) Skin pH (2) Redness nearly unchanged in
Comparator (5) Protein quantification both groups,
Emollient without (6) SC Protease activity (3) Increased SCH in intervention
these additives (7) Quantification of PCA (p = 0.003) and comparator
and lactate (p < 0.05),
(4) Decreased skin pH in
intervention (p = 0.005),
increased in comparator
(p < 0.001),
(5) No differences in proteins for
both groups,
(6) Increased SC proteases in
intervention vs. comparator
(p < 0.05, p < 0.0 0 01)
(7) Increase in lactate and PCA
(intervention vs. comparator
(p < 0.05)
(Continued on next page)
5
6
Table 2 (Continued).
control) generation
Federici et al. RCT Diabetics, treatment Intervention 4 weeks 40 66/58 (1) Severity of skin (1) Decreased in both groups using Yes Unclear Unclear Yes Yes No 3
(2012) of skin dryness Twice daily dryness (DASI) DASI; highest in intervention
application of (2) Severity of skin (p < 0.001),
Urea 5% cream dryness (VAS) (2) Decrease in both groups using
containing (3) Itch sensation VAS (p = 0.05),
arginine and (3) Decrease in both groups, no
carnosine difference between groups
Comparator
Emollient with
glycerol, Vaseline
and liquid
paraffin
Federici et al. RCT Diabetics, treatment Intervention 8 months 50 62/61 (1) Severity of skin (1) Decrease of skin dryness in Yes Unclear Yes Yes Yes Unclear 2
(2015) of skin dryness Twice daily dryness using Xerosis intervention vs. comparator
application of Assessment Scale using XAS (p < 0.001),
Urea 5% cream (XAS) (2) Decrease of skin dryness in
with arginine (2) Severity of skin intervention vs. comparator
0.4% and dryness using Overall using OCS (p < 0.02),
carnosine 0.01% Cutaneous score (OCS) (3) Increase in SCH in intervention
Comparator (3) SCH compared to baseline (p = 0.001),
Application of a (4) Desquamation (4) Reduced desquamation in
cream containing (5) Percentage of intervention (77% improvement)
40% glycerol patients with severe vs. comparator
dry skin and (5) Reduced severe skin dryness in
improvement ≥3 intervention vs. comparator
points after treatment (p = 0.004)
Gin et al. (2017) RCT Hospital/ Intervention 4 weeks 167 Median 62.9/65.2 (1) Complete healing of a (1) Complete healing after 4 Yes Unclear Yes Yes Unclear Unclear 3
Diabetologist/ Twice daily target fissure after 4 weeks: 46% intervention vs. 33%
General practices, application of a weeks (3-point scale) comparator (p = 0.09),
treatment of skin moisturizer (2) Complete healing of a (2) Complete healing after 2
dryness (healing containing 10% target fissure after 2 weeks: 8% intervention vs. 0
of deep open glycerin, 5% urea weeks (3-point scale) comparator (p = 0.01),
fissures on the and 8% (3) Clinical benefit (3) Improvement: Intervention
heel in diabetics) petrolatum (5-point scale) 54.4% (after 2 weeks), 68.8%
Comparator (4) Severity of dry skin (after 4 weeks) vs. comparator:
A placebo-cream (9-point scale) 24.4.% (after 2 weeks), 46% (after
(5) AEs 4 weeks);
(4) Decrease in xerosis in both
groups, highest in intervention
(p = 0.002);
(5) n = 4 AEs (in 3 patients)
intervention, n = 1 comparator
(study related; in total 8 AEs)
(pruritus, burning, inflammation,
heaviness)
Gillis et al. (2016) cRCT Nursing home, skin Intervention 12 weeks 163 86/82 (1) SCH (1) Increase in SCH in intervention Unclear Unclear No Yes Unclear No 3
dryness Washing with vs. comparator; highest on the
disposable wash cheek (p = 0.02)
gloves
Comparator
Traditional
washing method
Hahnel et al. RCT Nursing home, Intervention 8 weeks 133 83.8 (1) Severity of skin (1) Decreased skin dryness in all Yes Yes Yes Unclear Yes Yes 2
(2017a, 2017b), treatment of skin Two structured dryness (ODS) groups: right lower leg
dryness skin care (2) SCH (p = 0.121), left lower leg
regimens (3) TEWL (p = 0.073), right forearm
containing shea (4) Skin pH (p = 0.006), left forearm p = 0.011,
butter, glycerin trunk (p = 0.013),
(cleanser) and a (2) Increase in SCH in all groups:
W/O emulsion forearms (p = 0.691), legs
with 4% urea (p = 0.056),
Comparator (3) Increased TEWL in all groups:
Routine skin care forearm (p = 0.267), legs
(p = 0.773);
(4) Unchanged or slight increase in
skin pH in all groups: forearm
(p = 0.354), leg (p = 0.049)

control) generation
Hardy (1990) Quasi-experimental Nursing home, Intervention 18 weeks 15 70 (1) Skin dryness (1) Reduction of skin dryness na. 3
treatment of skin Twice weekly (2) Redness (p = 0.031)
dryness standardized (3) Flaking (2) Redness: p = 0.001 for changes
bathing regime (4) Scaling over time
using superfatted (5) Cracking (3) Scaling: p = 0.007 for changes
soap (Dove) and over time
mineral oil (4) Cracking: p = 0.406 for changes
Comparator over time
na. (5) Flaking: p = 0.002 for changes
over time
Hardy (1996) Quasi-experimental Nursing homes and Intervention 18 weeks 143 75 (1) Skin dryness (1) Reduction of skin dryness na. 3
outpatients, Standardized irrespective of bathing frequency
treatment of skin bathing regime
dryness using superfatted
soap (Dove) and
mineral oil using
various bathing
frequencies
Comparator
na.
Izumi et al. RCT Healthy subjects Intervention 1 4 weeks 50 57.2/57.6 (1) Severity of skin (1) Highest decrease of skin Unclear Unclear Unclear Yes Yes Unclear 3
(2017) with dry skin, Three times daily dryness (5-point scale) dryness on lower legs for
treatment of skin application of an (2) Severity of scratch intervention 1 and 2 (comparator
dryness emollient marks (5-point scale) vs. 10%+20% D/DC p < 0.001),
containing (3) Skin conductance untreated and white petrolatum
diethylene glycol/ (4) Itching (VAS) (p < 0.5),
dilinoleic acid (5) Quality of life (2) Highest reduction in scratch
copolymer 10% (Skindex-16) marks for intervention 1 and
Intervention 2 2 vs. comparator (p < 0.01),
An emollient (3) Highest increase in skin
containing conductance for intervention 1
diethylene glycol/ and 2 vs. comparator (p < 0.05);
dilinoleic acid (4) Itching decrease in all
copolymer 20% intervention-groups vs.
Intervention 3 comparator (p < 0.001)
White petrolatum (5) Quality of life increased in all
Comparator interventions, highest in
Untreated area intervention 2 (p < 0.001),
followed by intervention 3
(p < 0.05) and intervention 1
(p < 0.01)
Korponyai et al. Quasi-experimental Healthy subjects Intervention 1 14 days 12 Age range: 50 to (1) SCH (1) Increase in intervention 1 n.a. 3
(2016) with dry skin, Twice daily 60 (2) TEWL (p < 0.05 vs. baseline) and
treatment of skin application of (3) Skin friction Intervention 2 (p < 0.001 vs.
dryness Carbopol Ultrez (4) Sin elasticity baseline), slightly in control
10 0.4%, dissolved (5) Thickness of (20 vs. 23);
in purified water epidermis and dermis/ (2) Highest TEWL decrease in
Intervention 2 echogenicity of Intervention 2 (p < 0.001 vs.
A gel containing papillary dermis baseline; p < 0.05 vs.
5% glycerol- and (6) Protein quantity comparator);
5% xylitol (3) Highest increase in friction in
Comparator intervention 2 (p < 0.001 vs.
Untreated skin baseline; p < 0.05 vs.
comparator)
(4) Increase in elasticity in
intervention 2 (p < 0.05 vs.
baseline);
(5) Thickness increased in both
interventions, highest in
baseline), echogenicity decreased
in intervention 2 (p < 0.001 vs.
baseline, p < 0.05 vs.
comparator);
(6) Highest protein quantity in
comparator)
7
8
control) generation
Kuzmina et al. RCT Outpatients, Intervention 2 weeks 23 73 (1)Transepidermal water (1) Decrease of TEWL in both Unclear Unclear Unclear Yes Yes Yes 3
(2002) treatment of skin Twice daily loss groups; Difference between
dryness application of (2) Stratum corneum groups p = 0.24
oil-in-water hydration (2) Increase in SCH; differences
emulsion (3) Electrical impedance between groups p < 0.01
(40 mg/g urea) (3) Increase in electrical impedance
Comparator in both groups
Oil-in-water
emulsion
(40 mg/g urea and
40 mg/g sodium
chloride)
Martini et al. RCT Diabetics, treatment Intervention 28 days 57 58.3 (1) Skin dryness and (1) Decrease in skin dryness in Yes Yes Yes Yes Unclear Unclear 2
(2017) of skin dryness Twice daily fissures (XAS-Score intervention vs. comparator
on foot application of an and Overall skin score (p = 0.001 XAS-Score, p = 0.0002
emollient cream (ODS)) ODS-Score);
containing 15% (2) Effectiveness due to (2) Higher satisfaction (p = 0.022)
glycerol subject’s opinion (VAS) and preference (p = 0.015) for
Comparator (3) SCH intervention vs. comparator;
Control vehicle (4) Desquamation (3) Increase in SCH in intervention
(5) Skin relief vs. comparator (p = 0.005);
(6) AEs (4) Reduction in desquamation in
intervention vs. comparator
(p < 0.001);
(5) Decreased roughness in both
groups (greater reduction in
intervention vs. comparator);
(6) n = 2 cracks possible related to
intervention (local-regional,
reported by 2 subjects)
Okada et al. Quasi-experimental Nursing home Intervention 3 weeks 21 82 (1) Stratum corneum (1) Increase in SCH na. na
(2006) Two weekly hydration (2) Decrease in 2 residents
(abstract) application of (2) pH (3) Decrease in ceramide in
bathing detergent (3) Ceramide content nursing home residents
using (4) Sebum content (4) not reported
pseudo-ceramide (5) Bacterial flora (5) Slightly decrease in bacteria
Comparator
na. (before-after
evaluation)
Papanas et al. Quasi-experimental Diabetic outpatients Intervention 2 weeks 20 61 (1) Stratum corneum (1) SCH higher in Neuropad repair na. 3
(2011) Twice daily hydration foam compared to no treatment
application of (p < 0.001)
urea 10%,
alpha–hydroxy
acid, panthenol
containing foam
Comparator
No treatment
Pham et al. RCT Diabetic Intervention 8 weeks 40 62 (1) Skin dryness (1) Larger reduction of xerosis of Yes Yes Yes Yes Yes No 2
(2002) outpatients, Atrac-Tain cream (2) Development of new feet than in Atrac-Tain cream
treatment of skin (10% urea, 4% foot ulcers group compared to vehicle
dryness lactic acid) (p < 0.05)
Comparator (2) No ulcer development
Vehicle
Quatresooz et al. RCT Diabetic Intervention 5 weeks 30 59 (1) Stratum corneum (1) Increase of SCH in chitin-glucan Yes Yes Unclear Yes Yes Yes 2
(2009) (study menopausal Once daily hydration group compared to placebo
1) woman, application of (p < 0.01)
treatment of skin 1.5% chitin-glucan
dryness cream
Comparator
Placebo

control) generation
Quatresooz et al. RCT Diabetic Intervention 5 weeks 30 59 (1) Stratum corneum (1) Increase of SCH in both groups; Yes Yes Unclear Yes Yes Yes 2
(2009) (study menopausal Once daily hydration Differences between groups
2) woman, application of p = 0.061
treatment of skin crème
dryness piedsF́ormule
norvégienne
(“glycerol
enriched”,
Neutrogena,
France)
Comparator
crème
hydranteĆetaphil
(“glycerol
enriched”,
Galderma, France)
Schölermann RCT Outpatients, Intervention 6 weeks 60 64 (1) Stratum corneum (1) Increase of SCH in both groups; Unclear Unclear Yes No No Yes 3
et al. (1998) treatment of skin Twice daily hydration higher SCH in Eucerin 10% Urea
dryness application of (2) Skin dryness group compared to placebo
Eucerin 10% Urea (p < 0.05)
lotion (2) not reported
Comparator
Urea free vehicle
lotion
Schölermann RCT Outpatients Intervention 4 weeks 72 70 (1) Stratum corneum (1) Increase of SCH in Eucerin 10% Unclear Unclear Unclear No No Yes 3
et al. (1999) Twice daily hydration Urea and Eucerin Urea 10% with
application of (2) Skin dryness Panthenol and Bisabolol
Eucerin Cream compared to placebo (p < 0.01);
10% Urea vs. No difference between Eucerin
Eucerin Cream 10% Urea and Eucerin Urea 10%
10% Urea with 1% with Panthenol and Bisabolol
Panthenol and (2) not reported
0.07% Bisabolol
Comparator
Placebo
Sheppard and Quasi-experimental Nursing home Intervention 6 weeks 32 85 (1) Skin dryness (1) Reduction of skin dryness in na. 3
Brenner (20 0 0) Bag Bath/Travel (2) Redness Bag Bath/Travel Bath compared
Bath (3) Flaking to traditional bathing group
Control (4) Scaling (p < 0.001)
Traditional (5) Cracking (2) not reported
bathing (3) Difference between groups
p < 0.001
(4) Difference between groups
p < 0.001
(5) not reported
Sloane et al. RCT Nursing home Intervention 12 and 16 31 86 (1) Skin condition (1) No differences of skin condition Unclear No No/Yes Yes Yes Yes 3
(2007) Effects of four weeks between the four bathing
bathing regimens (p = 0.81)
procedures on
skin condition
Comparator
na.
Theunis et al. RCT Outpatients, Intervention 6 weeks 30 75.8 (1) Intensity of pruritus (1) Decrease in pruritus intensity Unclear No No Yes Yes Unclear 3
(2017) treatment of Application of (10 cm Visual Analog in intervention vs. comparator
chronic pruritus Rhealba® Oat Scale) (p < 0.0 0 01) and (2)
Extract-based (2) Intensity of pruritus (p = 0.0042);
emollient (French version of the (3) Decrease in skin dryness
Comparator 5-D itch scale) (p < 0.0 0 01);
Non-treatment (3) Skin dryness (4) Increase in SCH in intervention
(4) SCH vs. comparator (p < 0.0 0 01);
(5) Desquamation (5) Decrease in desquamation in
(6) TEWL intervention vs. comparator
(7) AEs (p < 0.0 0 01);
(6) No significant change in TEWL;
(7) n = 1 possible related AE
(pruritus)
9
10
control) generation
Weber et al. RCT Healthy subjects Intervention 1 3 weeks 49 64,03 (1) SCH (1) SCH increased in all Unclear No Unclear Yes Yes Unclear 3
(2012a) with very dry Twice daily (2) TEWL interventions and comparator
skin, treatment of application of (3) Skin dryness (5-point groups; highest increase in
skin dryness Light Formulation clinical grading score) intervention 1 (+17.3,
containing (4) Tactile p < 0.05) followed by
glycerin roughness(5-point intervention 3 (+10.2,
Intervention 2 clinical grading score) p < 0.05);
O/W emulsion ( = difference between (2) Decrease of TEWL in all
(vehicle) week 2 and baseline) interventions and comparator
Intervention 3 groups; highest increase in
Same emulsion intervention 1 (−1.4, p < 0.05)
enriched with 5% and intervention 3 (−1.2,
urea, sodium p < 0.05);
lactate, lactic acid (3) Highest decrease of skin
(vehicle plus) dryness in intervention 1
Comparator (−1.44, p < 0.05) and
Untreated area intervention 3 (−1.29,
p < 0.05);
(4) and in roughness intervention 1
(−1,44, p < 0.05), intervention
3 (−1.27, p < 0.05)
Weber et al. RCT Healthy subjects Intervention 1 3 weeks 44 59.9 (1) SCH (1) Increase of SCH in all Unclear No Unclear Yes Yes Unclear 3
(2012b) with very dry Twice daily (2) TEWL interventions and comparator
skin, treatment of application of (3) Skin dryness groups; highest increase in
skin dryness Rich Formulation (4) Tactile roughness intervention 1 (+21.7,
containing ( = difference between p < 0.05) and intervention 3
glycerin week 2 and baseline) (+8.6, p < 0.05);
Intervention 2 (2) Highest decrease in TEWL in
O/W emulsion intervention 1 (−3.7, p < 0.05)
(vehicle) and intervention 3 (−3.6,
Intervention 3 p < 0.05);
Same emulsion (3) Decrease of skin dryness in
enriched with intervention 1 (−1.20, p<0.05)
10% urea, sodium and intervention 3 (−0.80,
lactate, lactic acid p<0.05);
(vehicle plus) (4) Decrease in roughness in
Comparator intervention 1 (−0,97,
Untreated area p < 0.05), intervention 3
(−0.70, p < 0.05) and
intervention 2 (−0.39,
p < 0.05)
Weber et al. RCT Healthy subjects Intervention 18 days 44 66.5 (1) SCH (1) Increase in SCH in intervention Unclear No Unclear Unclear No Unclear 3
(2012c) with very dry Application of (2) Tactile roughness vs. comparator (p<0.05);
skin, treatment of Rich Formulation (2) Not reported
skin dryness (W/O) containing
glycerin
Comparator
Untreated area
Wehr et al. RCT Outpatients Intervention 12 weeks 56 52 (1) Skin dryness (1) Reduction of skin dryness in Unclear Unclear Unclear Yes Yes Yes 3
(1991) Twice daily both groups over time
application of (p < 0.001);
Lac-Hydrin Five Lower skin dryness scores in
(5% lactic acid) Lac-Hydrin Five group
Comparator (p < 0.001)
Eucerin lotion
Welzel et al. Quasi-experimental Outpatients Intervention 6 weeks 89 63 (1) Sebum content (1) Increase in sebum content and na. 3
(2006) Twice daily (2) Stratum corneum SCH (p < 0.001)
application of hydration (2) Decrease of SCH (p < 0.001)
hamamelis (3) Skin dryness (3) Decrease of skin dryness
ointment (4) Degree of fissures (p < 0.001)
Comparator (5) Itching (4) Decrease of fissures (p < 0.001)
na. (6) Adverse events (5) Slight decrease of itching
Wilson and Nix Quasi-experimental Nursing home Intervention 5 days 16 76 (1) Erythema (1) Reduction of erythema na. 3
(2005) Once daily (2) Dry scaly skin (p < 0.001)
application of (3) Presence of (2) Reduction of skin dryness
Sween 24 cream scratching (p < 0.001)
(6% dimethicone) (3) Reduction of scratching
Comparator (p = 0.016)
na.
Abbreviations: LoE, Level of Evidence according to the Oxford Center for Evidence-Based Medicine 2011; na, not applicable; RCT, randomized controlled trial; SCH, stratum corneum hydration; TEWL, transepidermal water loss.
Table 3
Summary of included studies for improvement of skin barrier.
Source Design Setting/ Sample/ Intervention Study n Mean age Outcomes Main results Risk of bias
Indication duration (years) Sequence Allocation Blinding Completeness Selection Other LoE
generation
Angelova- RCT Healthy subjects, Intervention 4 weeks 28 67.1 (1) Skin pH (1) Decrease in skin pH (p < 0.01) Unclear Unclear No Yes Yes Unclear 3
Fischer et al. improvement of Twice daily application of a (2) Roughness for intervention; unchanged for
(2018a) skin barrier pH 4 water in-oil (W/O) (3) Scaliness comparator;
integrity cream (4) TEWL (2) Small reduction in roughness
Comparator (5) SC cohesion for both creams;
pH 5.8 (W/O) cream (3) Decrease in scaliness in both
groups (p < 0.001)
(4) Decreased TEWL in
intervention (p < 0.001) vs.
comparator
(5) Reduced protein content after 4
weeks in both creams
(p < 0.001)
Angelova- RCT Healthy subjects, Intervention 1 24 h 10 64.5 (1) Irritation (1) No skin irritation on all test Unclear Unclear Unclear Unclear Yes Unclear 3
Fischer et al. skin barrier Application of a pH 4 (W/O) (2) Skin pH fields,
(2018b) recovery after cream (3) TEWL (2) Reduced skin pH after 3
induced skin Intervention 2 (p < 0.001) and 6 h (p < 0.01) of
impairment Application of a pH 5.8 induced skin damage in
(W/O) cream intervention 1; slight decrease in
Comparator 1 intervention 2 and both
Aceton comparators,
Comparator 2 (3) TEWL increased after 10 min of
Untreated skin skin damage (p < 0.01 vs.
baseline) and decreased after 6
(p < 0.05) and 24 h (p < 0.01) in
intervention 1; in intervention 2
and both comparators it
remained decreased
Behm et al. Quasi-experimental Elderly subjects, Intervention 4 weeks 30 70.2 (1) SCH (1) Increase of SCH (+12.1 units) n.a. 4
(2015a) improvement of Twice to four times daily (2) Skin pH vs. control;
epidermal barrier application of a glycolic (3) Subject evaluation (2) Decrease of skin pH (−0.52)
function acid-containing pH 4 (W/O) vs. control;
emulsion (3) not reported
Comparator/Control
Untreated volar forearm
Behm et al. RCT Diabetics, Intervention 2 weeks 10 70.2 (1) Skin pH (1) Decrease of skin pH in Unclear No No No Unclear Unclear 3
(2015b) improvement of Twice daily application of a (2) Bacterial colonization intervention vs. control
epidermal barrier glycolic acid-containing pH (p = 0.0 0 02);
function 4 (W/O) emulsion (2) Data not reported
Comparator/Control
Untreated foot
Blaak et al. RCT Nursing home, Intervention 7 weeks 26 87.0 (1) DASI-score (1) Decreased skin dryness in both Unclear Unclear Unclear Unclear Low risk Unclear 3
(2015) improvement of Twice daily application of a (2) SCH groups (pH 4 cream (p = 0.002);
skin barrier (O/W) cream containing (3) Skin pH pH 6 cream (p = 0.036)),
integrity synthetic detergent adjusted (4) TEWL (2) Increase in SCH in intervention
to pH 4 (5) SC integrity (p = 0.005); slight increase in
Comparator (6) SC recovery comparator (not significant),
The same cream (O/W) (7) SC cohesion (3) Skin pH decreased in
adjusted to pH 6 (Absorption) intervention (p = 0.003),
(8) Protein amount unchanged for comparator,
(9) Skin flora (cell count) (4) TEWL nearly unchanged in both
groups,
(5) Skin integrity increased in
intervention (p = 0.007), nearly
unchanged in control;
(6) Enhanced SC recovery in
intervention (p = 0.004),
unchanged in control,
(7) SC absorption unchanged in
intervention and impaired in
control (p = 0.025),
(8) Protein amount unchanged in
intervention and increased in
control (p = 0.025),
(9) Increase in CPU on skin flora in
both groups (p = 0.016 and
p = 0.017)
11
12
Source Design Setting/ Sample/ Intervention Study n Mean age Outcomes Main results Risk of bias
generation
Brooks et al. Quasi-experimental Nursing home/ Intervention 5 days 10 76.4 (1) TEWL (1) Greatest skin barrier n.a. 3
(2017) Outpatients, Daily application of five (2) SCH improvement (TEWL −1.14)
improvement of combinations of cleansing and (2) highest increase of SCH
skin barrier and emolliating products on (p = 0.011) for intervention of
function five 5 × 5 cm marked areas combination of soap, glycerine,
of a leg Vaseline vs. untreated area
Comparator/control
Untreated leg
Elewa et al. Quasi-experimental Healthy subjects Intervention 1 week No > 65 (1) Stratum corneum No data n.a. 3
(2012) Induction of skin barrier data hydration
(abstract) disruption by (2) Transepidermal water
tape-stripping; daily loss
application of two creams (3) Erythema
by LVMH
Comparator
DAC base cream
Farwick et al. Quasi-experimental Postmenopausal Intervention 1 12 weeks 40 50 to 70 (1) Sebum content (1) Increase in all three n.a. 3
(2014) females, Cosmetic formulations (2) Cutaneous blood formulations, highest in
improvement of containing 0.2% T. arjuna microcirculation intervention 1 (p < 0.001)
epidermal barrier bark extract added in (3) Skin density/ followed by intervention 2
function 1,2-pentanediol echogenicity (p < 0.01),
Intervention 2 (4) Sagging (2) Increase in microcirculation in
2.5% TEGO® Arjuna S. Soy intervention 1 vs. comparator
isoflavones (p < 0.001),
Comparator (3) Increase in echogenicity in
A formulation without intervention 2 (p < 0.001) and
active ingredients intervention 1 (p < 0.05) vs.
comparator,
(4) Reduction of sagging in groups,
highest in intervention 1 vs.
comparator (p < 0.01)
Narbut et al. Quasi-experimental Diabetics with Intervention 4 weeks 50 56.2 (1) Visual changes of (1) Reduced visible skin changes n.a. 3
(2016) healthy skin, Twice daily application of (6 skin properties (baseline vs. 4 weeks p < 0.05);
maintaining skin Emolium Diabetix weeks (erythema, (2) Increase in SCH (baseline vs. 4
integrity containing urea and glycerin with desquamation, weeks p < 0.05), (3) skin pH
Comparator follow- roughness, dryness) (baseline vs. 4 weeks p < 0.05)
None up) (4-point scale) and (4) sebum (baseline vs. 4
(2) SCH weeks p < 0.05);
(3) Skin pH (5) Decrease in TEWL (baseline vs.
(4) Sebum content 4 weeks p < 0.05);
(5) TEWL (6) 90% patient satisfaction, 56%
(6) Satisfaction of physician;
product use (7) No significant change in SAF
(7) Skin autofluorescence (baseline vs. 4 weeks p = 0.42)
Paulela et al. RCT Hospital, Intervention 5 days 55 ≥60 (1) Skin microbial load (1) Reduction in microbial load in No No No Yes Yes Yes 3
(2018) effectiveness in Washing with bag bath intervention vs. comparator
microbial load of Comparator (p < 0.001)
the skin Conventional bed bath with
cleanser and water
Roure et al. Quasi-experimental Healthy subjects Intervention 1 day 12 62 (1) Stratum corneum (1) Application of lotion before n.a. 4
(2012) Application of lotion hydration wind exposure increases SCH,
containing glycerine and (2) Transepidermal water decrease of SCH after wind
subsequent simulated loss exposure without lotion
exposure of dry and cold (2) not reported
wind
Comparator
Untreated with wind
Schoonhoven Cluster-RCT Nursing homes, Intervention 6 weeks 500 82.4 (1) Prevalence of skin (1) No differences in skin damage Yes Unclear No Unclear Yes Yes 3
et al. (2015) maintaining skin Washing without water damage between groups (p < 0.820)
integrity and using bag bath: Washing (slightly decrease in any skin
resistance gloves made of soft waffled abnormalities/lesions in
nonwoven fibers, intervention, slightly increase in
impregnated with skin comparator, resulting in 72.7% vs
cleaning and caring lotion 77.6% of residents
Comparator having any skin
Traditional bed bath abnormalities/lesions after 6
weeks (p = 0.04); no significant
differences in skin lesions or
resistance after 6 weeks between
groups
Table 4
Summary of included studies for prevention and treatment of incontinence-associated dermatitis.
Source Design Setting/ Sample/ Intervention/control Study n Mean age Outcomes Main results Risk of bias
generation
Beeckman RCT Nursing home/IAD Intervention 120 days 141 86 (1) Prevalence of IAD (1) Decrease of IAD prevalence Yes No No Yes Yes No 3
et al. (2011) prevention 2-in-1 perineal care (2) Severity of IAD (p = 0.003) and severity
washcloth (3% (p = 0.06) in intervention group;
dimethocone) for IAD larger decrease of IAD prevalence
prevention in intervention group compared
Comparator to control group (p = 0.003)
Water and soap (2) Improvement of IAD severity in
intervention group (p < 0.001 for
change over time)
Bliss et al. Quasi-experimental Nursing home/ IAD Intervention 6 weeks 981 65+ (1) IAD incidence (1) IAD incidence: 33/981 (3.4%), na. 4
(20 06, 20 07) prevention Barrier film (spray acrylate) difference between groups
Comparator 1 p = 0.55
Ointment (43% petrolatum)
Comparator 2
Ointment (98% petrolatum)
Comparator 3
Barrier cream (12% zinc
oxide, 1% dimethicone)
Byers et al. Quasi-experimental Nursing home/ IAD Intervention 15 weeks 12 87 (1) Transepidermal water (1, 2, 3) No differences in TEWL, na. 4
(1995) prevention No-rinse incontinence loss pH, and erythema between
cleanser for IAD prevention (2) pH treatment groups
Comparator 1 (3) Erythema
Soap and water and
moisture barrier
Comparator 2
No-rinse incontinence
cleanser and moisture
barrier
Brunner et al. RCT Hospital, Intervention Hospital 64 67.3 (1) Degree of skin (1) No differences between groups, No No No Yes Yes Yes 3
(2012) incontinent Washcloth combined with stay breakdown (2) Average time to skin
patients, IAD cleanser, moisturizer, and (2) Time to skin breakdown longer in comparator
prevention barrier impregnated with breakdown group (p = 0.045)
3% dimethicone
Comparator
pH-balanced, no-rinse
cleanser and moisturizer
containing glycerin and
dimethicone and a film
forming polymeric solution
spray
Conley et al. RCT Hospital (critically Intervention 9 month 99 75/67 (1) IAD score (Brown’s (1) Moderate IAD score decreased No No No Yes Yes No 3
(2014) ill patients in PUC Skin care protocol every 6 h grading scale) for intervention group (7.1% vs.
ward, IAD including gently skin 10.9%) (p ≤ 0.001), mild IAD
prevention cleansing with a aloe vera decreased in control-group
containing cleansing lotion (43.6% vs. 25.5%) (p ≤ 0.001); no
and application of a skin statistical significant differences
barrier containing silicone for no IAD and severe IAD
Comparator
Skin care protocol every
12 h including gently skin
cleansing with a aloe vera
containing cleansing lotion
and application of a skin
barrier containing silicone
Cooper et al. RCT Nursing home/ Intervention 14 days 30 81 (1) Skin integrity (1) Slight increasing of patients Unclear Unclear No/Yes Yes Yes No 3
(2008) Reha-bilitation Tena Wash Mousse with intact skin in both groups,
center/IAD (emollients) no difference between groups
prevention Comparator
Clinisan Foam Cleanser
(amphoteric surfactants,
triclosan, dimethicone)
13
14
Source Design Setting/ Sample/ Intervention/control Study n Mean age Outcomes Main results Risk of bias
generation
Cooper and RCT Nursing home/IAD Intervention 14 days 93 82 (1) Skin condition (1) Larger proportion of residents Unclear No No/Yes Yes Yes No 3
Gray (2001) prevention Clinisan (Vernacare) foam in foam cleanser group with
cleanser (amphoteric intact skin (66%) to soap group
surfactants, triclosan, (37%) (p = 0.05)
dimethicone)
Comparator
Soap (non-perfumed) pH
9.5–10.5 (1% aqueous
solution) and water
Kon et al. RCT Nursing home, Intervention 14 days 33 Median (1) Erythema (1) Decrease of erythema index in Unclear Unclear No Yes Yes No 3
(2017) patients with IAD Once daily use of a skin 86/82 (2) Pigmentation intervention vs. control
of the buttock or cleanser containing (3) Sulcus cutis thickness (p = 0.004);
inner thigh/IAD emollient, copolymer and (4) Sulcus cutis interval (2) No change in pigmentation
treatment dimethicone and the (5) SCH between both groups (p = 0.307);
application of a skin (6) Dermis hydration (3) Increase in thickness in
protectant containing (7) TEWL intervention and control
isopropyl palmitate, acrylate (8) Skin pH (p = 0.708);
terpolymer and dimethicone (4) For interval no change in both
three times daily groups (p = 0.259);
Comparator (5) Increase in SCH in intervention
Cleansing with wet towels vs. control (p = 0.100);
after each pad change and (6) Nearly no change in dermis
use of the same skin hydration in both groups
cleanser once daily without (p = 0.155);
using a moisturizer for (7) Higher decrease in TEWL in
improving IAD severity intervention vs. control
(p = 0.093);
(8) Slight decrease in skin pH for
intervention vs. control
(p = 0.093)
Lewis-Byers RCT Nursing home/IAD Intervention 3 weeks 32 70 (1) Perineal skin (1) Better skin condition in No No No Yes Yes No 4
and Thayer prevention No-rinse liquid cleanser and condition no-rinse cleanser and barrier
(2002) barrier cream (2) Pain cream group compared to water
Comparator and soap (not statistically
Soap and water followed by significant)
application of moisturizing (2) Slight increase in pain in
lotion after incontinence intervention group (not
episode statistically significant)
Lyder et al. Quasi-experimental Geriatric/ Intervention 10 weeks 15 75 (1) IAD incidence (1) No reduction of IAD incidence na. 4
(1992) IAD prevention Structured skin care
regimen including
application of cleansers and
moisturizers
Comparator
na.
Park and Kim Quasi-experimental Hospital (ICU), Intervention 7 days 76 68.8/ 69.7 (1) IADS score (1) Lower score for intervention n.a. 3
(2014) patients with A structured skin care (2) PU incidence (p<0.001);
fecal regimen (including skin and (2) Higher incidence in
incontinence, IAD stool assessment, control-group (13.2% vs 50%,
and pressure interventions (e.g. p<0.001)
ulcer risk structured skin care after
incontinence, mild washing,
use of skin care products)
Comparator
Standard skin care protocol
Warshaw et al. Quasi-experimental Nursing home/IAD Intervention 7 days 19 73 (1) Erythema score (1, 2) Reduction of erythema and na. 3
(2002) prevention Cleanser barrier lotion (2) Pain score pain (p < 0.01)
Comparator
na.
Zehrer et al. Descriptive Nursing home/IAD Intervention 6 month 250 83 (1) IAD incidence (1) No difference in IAD incidence na. 4
(2004) prevention Barrier film once daily between groups (p = 0.55)
Comparator 1
Protective ointment as
needed
Comparator 2
Barrier film three times per
week
Abbreviations: IAD, incontinence-associated dermatitis; LoE, Level of Evidence according to the Oxford Center for Evidence-Based Medicine 2011; PU, pressure ulcer; RCT, randomized controlled trial.
Table 5
Summary of included studies for prevention and treatment of skin tears and pressure ulcers.
Source Design Setting/ sample/ Intervention/control Study n Mean age Outcomes Main results Risk of bias
indication duration (years) Sequence Allocation Blinding Completeness Selection Other LoE
generation
Skin tears
Birch and Retrospective Nursing home /skin Intervention 4 month 29 80 to 82 (1) Skin tears (1) Reduction of skin tear incidence na. 4
Coggins tears prevention One-step no-rinse cleanser
(2003) Comparator
na.
Carville et al. RCT Nursing home, skin Intervention 6 month 984 87.13/ 85.95 (1) Monthly skin tear (1) Intervention-group lower Unclear Unclear Unclear No Yes Yes 3
(2014) tear prevention Twice daily application of a incidence monthly incidence vs. control
standardized commercially (2) Cumulative incidence (p = 0.004)
available moisturizing lotion (3) Number of skin tears (2) Lower cumulative incidence in
containing glycerin (4) Anatomical location the intervention-group (41% vs.
Comparator of skin tears 59%);
Skin care as “usual” (5) STAR classification (3) 172 ST (40.6%) in intervention
group, 252 ST (59.4%) in
control-group,(4) Mostly
developed on upper limb
(Intervention vs. control: 59% vs.
44%) (5) Mostly 1a (31% vs. 45%)
an 1b (32% vs. 24%)
Finch et al. Quasi-experimental Hospital, skin tear Intervention 18 month 1177 89.9/ (1) Monthly incidence (1) Decreased incidence in n.a. 3
(2018) prevention Twice-daily application of a 87.8 rate intervention-group (4.4) vs.
moisturizer containing (2) Number of skin tears control-group (6.6) (p = 0.006);
glycerin and petrolatum (3) Anatomical location (2) n = 185 skin tears in total;
Comparator (4) STAR classification n = 60 (7.9%) patients in
“usual care” intervention-group, n = 44
(10.6%) patients in control-group
(3) Mostly on lower limb (about
55% intervention/ 56% control);
(4) Mostly 1b (46.8% intervention,
49.2% control)
Groom et al. Retrospective Nursing home/ skin Intervention 12 month 200 65+ (1) Skin tear incidence (1) Higher skin tear incidence in na. 4
(2010) tear prevention Surfactant-based cleanser (2) Number of skin tears surfactant-based cleanser and
and moisturizer/barrier moisturizer/barrier cream group
cream (dimethicone) compared to phospholipid-based
Comparator cleanser (p < 0.001)
Phospholipid-based cleanser (2) not reported
and moisturizer/barrier
cream (dimethicone)
Mason (1997) Quasi-experimental/ Nursing home Intervention 5 month 43 86 (1) Incidence of skin (1) Lower skin tear incidence in na. 4
skin tear Non-emollient soap tears emollient soap group (p = 0.082)
prevention Comparator (2) Skin quality (2) not reported
Emollient soap for
Pressure ulcers
Clever et al. Retrospective Nursing home/ PU Intervention 180 days 64 83 (1) Pressure Ulcer (1) Lower PU incidence in na. 4
(2002) prevention All-in-one disposable incidence intervention group compared to
washcloth (dimethicone) vs. standard care group (p = 0.015)
standard care
Comparator
Period before the
interventional product was
used of 90 days
15
16
Source Design Setting/ sample/ Intervention/control Study n Mean age Outcomes Main results Risk of bias
indication duration (years) Sequence Allocation Blinding Completeness Selection Other LoE
generation
Hunter et al. Quasi-experimental Nursing home/ Skin Intervention 6 month 83 81 (1) Incidence of “skin (1) Reduction of “skin breakdown” na. 3
(2003) breakdown and Skin protectant (50% breakdown” incidence after implementation
PU prevention lanolin, beeswax, (2) Pressure ulcer of skin protectant and body
petrolatum) and body wash incidence wash (p = 0.007);
Comparator (2) No reduction of PU incidence
Nursing care “per normal (p = 0.437)
agency routine” for 3
months
Lupianez-Perez RCT Home nursing Intervention 16 weeks 831 80.6 (1) Incidence of PUs (1) Higher PU incidence with the Yes Yes Unclear Unclear Unclear Yes 3
et al. (2015) service, pressure Twice daily application of (Stage 2 or higher) use of HOFA compared to olive
ulcer prevention olive oil (2) Skin integrity oil on both heels and trochanter
Comparator (same incidence for sacrum) (per
Hyperoxygenated fatty acids protocol analysis) p value?
(HOFA) (2) No differences between groups
Thompson Quasi-experimental Nursing home/PU Intervention 6 month 136 81 (1) Prevalence of (1) 11.3% pre-intervention, 4.8% na. 3
et al. (2005) prevention Skin care protocol including category I and II post-intervention (p = 0.244)
application of a cleanser pressure ulcers (2) 32.7% pre-intervention, 8.9%
and skin protectant (50% (2) Incidence of category post-intervention (p = 0.01)
lanolin, beeswax, I and II pressure ulcers (3) n = 35 pre-intervention, n = 14
petrolatum) (3) Number of category I post-intervention (p = 0.05)
Comparator and II pressure ulcers Slight increase of patients with
na. intact skin in both groups, no
difference between groups
Torra i Bou RCT Nursing home/ Intervention 30 days 380 84 (1) Incidence of pressure (1) 12/164 (7.3%) in Yes Yes Yes Yes Yes No 2
et al. (2005) Hospital/ PU Mepentol (various oils) ulcers intervention-group; 29/167
prevention Comparator (17.4%) in placebo-group
Placebo (p < 0.006), RR = 0.42 (95% CI
0.22 to 0.80)
Verdú and RCT Hospital patients Intervention 2 weeks 194 78.2/ 78.5 (1) Pressure ulcer (1) Intervention 6.1%, control 7.4%, Yes Yes Yes Yes Unclear Unclear 2
Soldevilla with high Application of incidence no difference between groups;
(2012) pressure ulcer IPARZINE-SKR every 12 h (2) AEs (2) AEs not reported
risk, pressure Comparator
ulcer category I Placebo
prevention
The application of a formulation with 10% glycerin, 5% urea with water (Level of Evidence 3), but a difference of the preva-
and 8% petrolatum resulted in complete healing of deep fissures lence of skin damages was not observed (Schoonhoven et al., 2015)
in nearly half of all included diabetics with very dry skin on feet (Level of Evidence 3).
compared to 30% in control group but dry skin severity decreased In a tightly controlled simulation study the combination of
in both groups (Level of Evidence 3) (Gin et al., 2017). soapy water, boiled tap water with 2% glycerin and afterwards the
The application of formulations containing plant-based addi- application of Vaseline showed the greatest skin barrier improve-
tives like oil emulsion adjusted to pH 4 (Blaak et al., 2017), oat ment regarding transepidermal water loss decrease and stratum
extract (Theunis et al., 2017) or sunflower oil (Chang et al., 2018) corneum increase (Brooks et al., 2017) (Level of Evidence 3).
resulted in an increased stratum corneum hydration (Blaak et al.,
2017; Chang et al., 2018; Theunis et al., 2017) (Level of Evidence 3.5. Preventing and treating incontinence-associated dermatitis
3), decreased transepidermal water loss (Blaak et al., 2017; Chang
et al., 2018) (Level of Evidence 3) and reduced pruritus intensity The implementation of structured skin care protocols was
(Theunis et al., 2017) (Level of Evidence 3). Highest improvement investigated in 13 studies (Table 4). Cleansers and washcloths
in dry skin was achieved for an emollient containing dilinoleic acid containing low-irritating surfactants, dimethicone and emollients
20% compared to 10% and petrolatum (Izumi et al., 2017) (Level of showed skin protecting effects compared to standard care such as
Evidence 3). using water and traditional soap (e.g. Beeckman et al., 2011, Cooper
et al. 2001, Warshaw et al., 2002) (Level of Evidence 3). When
3.3.2. Cleansing and complex skin care regimens comparing these cleansers and strategies directly with each other
Six studies described skin cleansing procedures to treat dry no differences were observed (Brunner et al., 2012; Byers et al.,
skin. Bathing using a superfatted soap and mineral oil reduced 1995; Cooper et al., 2008) (Level of Evidence 3).
signs of dry skin (Hardy 1990, 1996) (Level of Evidence 3) but The application of skin protectants such as barrier films,
Sloane et al. (2007) found no difference in skin condition between lipophilic leave-on products such as petrolatum containing prod-
four different bathing regimes consisting of whirlpool tub or ul- ucts reduced the incontinence- associated dermatitis incidence
trasound tub using standard soap products or specialized soap and compared to using no skin protectant (Kon et al., 2017) (Level of
“skin conditioners” and still water with standard soap (Level of Ev- Evidence 3). Direct comparisons between skin protectants revealed
idence 3). Washing with disposable wash gloves increased skin hy- no differences (Bliss 20 06, 20 07, Lewis-Byers and Thayer, 2002,
dration compared to traditional washing (Gillis et al., 2016) (Level Zehrer et al., 2004) (Level of Evidence 4). The application of a skin
of Evidence 3). A structured skin care regimen consisting of a body protectant containing isopropyl palmitate, acrylate terpolymer and
wash contained shea butter and glycerin compared to another skin dimethicone improved the skin integrity and reduced the severity
care regimen including the use of a glycerin containing body wash of incontinence- associated dermatitis compared the application of
and application of an emollient containing 4% urea reduced skin a skin care protocol conducted every 6 h with every 12 h in pa-
dryness in both interventions but in the control group as well. tients with incontinence-associated dermatitis (Conley et al., 2014).
Transepidermal water loss and skin surface pH remained nearly The intervention comprised gently skin cleansing with an aloe vera
unchanged in all intervention and control groups (Hahnel et al., containing lotion and application of a skin protectant containing
2017a, 2017b) (Level of Evidence 2). A combination of a body wash silicone. Incontinence-associated dermatitis severity was reduced
and a moisturizer containing sunflower seed oil, panthenol and in both groups (Level of Evidence 3). Park and Kim (2014) eval-
shea butter with stearic acid, linoleic acid and catechins increased uated a complex skin care regimen comprising skin assessment
skin hydration and reduced severity of clinical signs of skin dry- on admission, structured skin care immediately after every incon-
ness after 14 days (Chang et al., 2018) (Level of Evidence 3). tinence episode, mild washing, use of skin care products, educa-
tion of care givers compared to standard skin care. The severity
of incontinence-associated dermatitis and pressure ulcer incidence
3.4. Improving skin barrier function was decreased after seven days (Level of Evidence 3).
3.4.1. Application of leave-on skin care products 3.6. Preventing skin tears
Twelve studies evaluated effects of different formulations or
washing methods to improve skin barrier integrity. Angelova- Using ‘one-step’ no-rinse cleansers or emollient soaps reduced
Fischer et al. (2018) compared two formulations with pH 4 and skin tear incidence compared to standard soap (Mason 1997; Birch
pH 5.8 regarding enhancement of skin barrier integrity. The pH and Coggins 2003) (Level of Evidence 4) (Table 5). Comparing to
4 formulation showed better effects in skin barrier improvement a phospholipid based cleanser there was a higher skin tear inci-
due to a decrease in skin surface pH, transepidermal water loss dence in the surfactant-based cleanser group (Groom et al., 2010)
and scaliness (Level of Evidence 3). Formulations with pH 4 de- (Level of Evidence 4). The application of leave-on products con-
creased skin surface pH and improved skin barrier integrity (Behm taining glycerin and petrolatum reduced the incidence of skin tears
et al., 2015; Blaak et al., 2015). A plant-based formulation showed (Carville et al., 2014; Finch et al., 2018) (Level of Evidence 3).
improving effects on the epidermal barrier in postmenopausal fe-
males regarding microcirculation, skin density, sebum and sagging 3.7. Preventing pressure ulcers
(Farwick et al., 2014) (Level of Evidence 3). Application of an urea
and glycerin containing cream showed skin improvement effects Results of the six studies preventing pressure ulcers are shown
in diabetics (Narbutt et al., 2016) (Level of Evidence 3). In a sim- in Table 5. The use of structured skin care regimens such as us-
ulation study the application of a glycerine contain leave-on prod- ing a disposable washcloth containing dimethicone (Clever et al.,
uct before wind exposure caused increased stratum corneum hy- 2002) or using a cleanser in combination with a skin protectant
dration compared to untreated skin (Roure et al., 2012, Level of (Hunter et al., 2003; Thompson et al., 2005) reduced pressure ul-
Evidence 4). cer incidence (Level of Evidence 3 to 4). In a placebo-controlled
RCT there was no difference in pressure ulcer incidence between
3.4.2. Cleansing and complex skin care regimens the application of a cream containing iparzine in comparison to
Cleansing with a bag bath reduced the microbial load of the placebo (Level of Evidence 2) (Verdu and Soldevilla, 2012). In an-
skin (Paulela et al., 2018) in comparison to traditional washing other study, the application of olive oil was compared to hyper-
oxygenated fatty acids. Pressure ulcer incidence was slightly lower products (Level of Evidence 3). This is in accordance with the re-
in the olive oil-group and differences regarding skin barrier im- sults of the previous review and guidance in the field (Guenther
provement were not observed (Lupianez-Perez et al., 2015) (Level et al., 2012; Kottner et al., 2013). However, results of direct head-
of Evidence 3). to-head leave-on comparisons are inconclusive. Depending on the
chosen comparator, the performance of formulations containing
3.8. Outcome domains and measurement instruments humectants such as urea, glycerin or lactate in different concen-
trations seems to be better compared to vehicles without these
Thirty-five outcome domains were identified (Table 6). Per out- humectants, but overall skin dryness and skin barrier properties
come domain, high numbers of outcome measurement instru- also improved in control groups. Review results also indicate, that
ments were found. For instance, the outcome domain “clinical a structured approach is better than an unstructured or no skin
signs of skin dryness” was measured with 17 different instruments care regimen for improving skin dryness (Level of Evidence 2 and
in 13 studies (Blaak et al., 2015; Chang et al., 2018; Cristaudo et al., 3). Overall, these results indicate, that lipophilic leave-on products
2015; Federici et al., 2012; Federici et al., 2015; Gin et al., 2017; containing basic ingredients such as petrolatum with or without
Hahnel et al., 2017a, 2017b, 2017c, Izumi et al., 2017; Martini et al., humectants are helpful for treating dry skin in aged care settings.
2017; Narbutt et al., 2016; Theunis et al., 2017; Weber et al., 2012). Based on the current evidence it is unclear, whether one product
Different clinical scales containing 4 to 10 items were used to mea- or a certain ingredient is better than another. It is widely accepted
sure the severity of skin dryness. Several clinical signs were as- that effects on the skin are always based on the total formulation.
sessed, e.g. erythema, scaling, roughness or excoriations. It is not the presence or absence of a single ingredient (Kottner
Seven instruments were used to measure pruritus or itch and Surber 2016).
(Chang et al., 2018; Cristaudo et al., 2015; Federici et al., 2012;
Izumi et al., 2017; Theunis et al., 2017). Pruritus severity was as- 4.2. Interventions for skin barrier improvement
sessed using different scales or by a 22-item questionnaire.
The most often applied outcome measurement instruments for Five of 10 studies investigated effects of leave-on products with
stratum corneum hydration was the Corneometer (Blaak et al., an acidic pH of 4. These products seem to be more helpful to
2017; Blaak et al., 2015; Chang et al., 2018; Cristaudo et al., 2015; maintain and improve the skin barrier compared to no treatment
Danby et al., 2016; Hahnel et al., 2017a, 2017b, 2017c, Kon et al., (Level of Evidence 3 and 4) and products with higher pH (Level
2017; Korponyai et al., 2017; Martini et al., 2017; Narbutt et al., of Evidence 3). Similar to the treatment of dry skin, review results
2016; Theunis et al., 2017; Weber et al., 2012), but additionally indicate that the application of skin care products is better than
further three instruments were used. The most often applied no treatment for skin barrier improvement (Brooks et al., 2017;
instrument for assessments of skin surface pH was the Skin pH Narbutt et al., 2016), but differences between formulations seems
Meter PH905 (Angelova-Fischer et al., 2018; Blaak et al., 2017; to be low (Farwick et al., 2014) (Level of Evidence 3). The use of
Blaak et al., 2015; Danby et al., 2016; Hahnel et al., 2017a, 2017b, traditional washing compared to ‘bag baths’ seems to make no dif-
2017c, Kon et al., 2017; Narbutt et al., 2016). For the measurement ference in terms of overall skin integrity (Schoonhoven et al., 2015)
of transepidermal water loss most studies used the Tewame- (Level of Evidence 2). Taken together these results indicate, that se-
ter (Angelova-Fischer et al., 2018; Chang et al., 2018; Cristaudo lecting leave-on products with a more acidic pH has advantages for
et al., 2015; Hahnel et al., 2017a, 2017b, 2017c, Korponyai et al., skin barrier improvement in aged skin.
2017; Narbutt et al., 2016; Weber et al., 2012), but three other
instruments were also applied (Blaak et al., 2017; Blaak et al., 4.3. Preventing and treating incontinence-associated dermatitis
2015; Brooks et al., 2017; Danby et al., 2016; Kon et al., 2017;
Theunis et al., 2017). Some outcome domains like “skin scali- Published quasi-experimental studies and RCTs showed that us-
ness/desquamation” or “skin surface roughness” were assessed ing mild cleansers and skin care and barrier products are helpful
using devices or clinical grading scales (Angelova-Fischer et al., for preventing and treating incontinence-associated dermatitis but
2018; Federici et al., 2015; Narbutt et al., 2016). differences between strategies and products are unclear (Level of
Evidence 3 and 4). This indicates that a structured skin cleans-
ing and protection regimen is better than doing nothing, but per-
4. Discussion formance differences between products or strategies are unclear.
These results are similar to the previous review (Kottner et al.,
Skin care is an integral part of nursing practice and this work 2013) and are supported by conclusions in the latest Cochrane re-
provides an up-to date comprehensive broad summary of available view for the prevention and treatment of incontinence-associated
evidence of the effects and effectiveness of skin care interventions dermatitis (Beeckman et al., 2016) and by recent guidance in the
in aged populations. field (Beele et al., 2018).
One major result of this review update is, that between 2012
and 2018 more relevant studies were published compared to the 4.4. Preventing skin tears and pressure ulcers
much longer search period from 1990 to 2012 in the previous re-
view (Kottner et al., 2013). This indicates increasing interest in Review results indicate, that the application of leave-on prod-
this topic. Included studies address skin dryness, followed by gen- ucts containing basic ingredients such as glycerin and petrolatum
eral strategies to enhance skin integrity, prevention and treatment prevents skin tear occurrence in the aged (Level of Evidence 2 and
of incontinence-associated dermatitis, prevention of skin tears and 3). Results of quasi-experimental studies suggest, that mild skin
pressure ulcers. This corresponds to the load of these skin condi- cleansing and skin protection might be helpful for preventing su-
tions in aged populations (Hahnel et al., 2017a, 2017c), and they perficial pressure ulcers (Level of Evidence 4) but because a non-
are all relevant to nursing practice (Kottner et al., 2019a, 2019b). treatment groups are lacking in the included RCTs these results do
not provide strong evidence that the application of topical products
4.1. Preventing and treating dry skin reduces pressure ulcer development per se. This also fits to the
current understanding of the etiology of pressure ulcers starting
Study results consistently indicate, that the use of leave-on in deeper subcutaneous tissues (Kottner et al., 2019a, 2019b). This
products is effective in treating signs of dry skin compared to no interpretation is supported by the latest Cochrane review about
Table 6
Outcome domains and measurement instruments or techniques.
Outcome domains (what?) Outcome measurement instruments/techniques (how?) References
(1) Skin dryness (clinical signs) (1) Dry skin area and severity index (DASI) Blaak et al. (2015) and Federici et al.
(2012)
(2) Xerosis assessment Scale (XAS) Federici et al. (2015) and Martini
et al. (2017)
(3) Dry skin 5-point severity scale Chang et al. (2018)
(4) Fissures (Complete healing of a target fissure according to a 3-point Gin et al. (2017)
scale: healed fissures, superficial closed fissures or deep open fissures after
2 and 4 weeks of treatment),
(Clinical benefit of treatment on fissure improvement (5-point scale: 1
(strong improvement) to 5 (worsening))
(5) Severity of scaling (4-point scale (absent (0), mild (+), moderate (++), Cristaudo et al. (2015)
severe (+++))
(6) Severity of skin tightness (4-point scale) Cristaudo et al. (2015)
(7) Severity of fissuring (4-point scale) Cristaudo et al. (2015)
(8) Severity of excoriations (4-point scale) Cristaudo et al. (2015)
(9) Severity of Erythema (4-point scale) Cristaudo et al. (2015)
(10) Visual change in erythema severity (4-point scale) Narbutt et al. (2016)
(11) Severity of skin dryness via VAS (10-point scale: 0 = extreme skin Federici et al. (2012)
dryness to 10 = best skin hydration state imaginable)
(12) Severity of xerosis according to a 9-point scale (0 (normal skin) to 8 Gin et al. (2017)
(deep fissuring))
(13) Severity of skin dryness via Overall Cutaneous score (OCS) (0 = normal Federici et al. (2015)
skin to 3 = severe hyperkeratosis)
(14) Overall dry skin score (ODS) (5-point scale: 0 = no skin dryness to Hahnel et al. (2017a, 2017b, 2017c)
4 = advanced skin roughness, large scales, inflammation and cracks) and
Theunis et al. (2017) (French
translation)
(15) Severity of skin dryness on the lower legs (5-point scale: 0 = none to Izumi et al. (2017)
4 = severe)
(16) Visual change in skin dryness severity (4-point scale: 1 = lack of any Narbutt et al. (2016)
change, 2 = low severity changes, 3 = moderate severity changes,
4 = greatest severity changes)
(17) Skin dryness via 5-point clinical grading score Weber et al. (2012a, 2012b)
(2) Pruritus/itch (1) Pruritus (ItchyQolTM , a 22-item questionnaire) Chang et al. (2018)
(2) Itching (scale from 0 (no itching) to 10 (severe itching)) Cristaudo et al. (2015)
(3) Itch sensation (10-point scale: 0 = extreme itch to 10 = no itch) Federici et al. (2012)
(4) Severity of scratch marks (pruritus) on the lower legs (5-point scale: Izumi et al. (2017)
0 = none to 4 = severe)
(5) Itching (VAS) Izumi et al. (2017)
(6) Intensity of Pruritus via 10 cm Visual Analog Scale Theunis et al. (2017)
(7) Intensity of Pruritus via French version of the 5-D itch scale Theunis et al. (2017)
(3) Stratum corneum hydration/ (1) Corneometer Blaak et al. (2015),
Dermal hydration Danby et al. (2016),
Behm et al. (2015a),
Blaak et al. (2017),
Chang et al. (2018),
Cristaudo et al. (2015),
Hahnel et al. (2017a, 2017b, 2017c),
Kon et al. (2017),
Korponyai et al. (2016),
Martini et al. (2017),
Narbutt et al. (2016),
Theunis et al. (2017) and
Weber et al. (2012a, 2012b, 2012c)
(2) MoistureMeterSC Brooks et al. (2017) and
Gillis et al. (2016)
(3) Bio-impedance skin analysis device (Hydr8) Federici et al. (2015)
(4) MoistureMeter D Kon et al. (2017)
(4) Skin surface pH (1) Skin pH Meter PH905 Blaak et al. (2015),
Danby et al. (2016),
Angelova-Fischer et al. (2018a,
2018b),
Blaak et al. (2017),
Hahnel et al. (2017a, 2017b, 2017c),
Kon et al. (2017) and
Narbutt et al. (2016)
(2) Skin pH Electrode by SI Analytics GmbH, Mainz, Germany Behm et al. (2015a, 2015b)
(5) Skin tears (1) Incidence Carville et al. (2014)
(2) Number of skin tears Carville et al. (2014)
(3) Anatomical location of skin tears Carville et al. (2014)
(4) Classification of skin tears by STAR (Skin Tear Classification) Carville et al. (2014)
(6) Transepidermal water loss (1) Tewameter Hahnel et al. (2017a, 2017b, 2017c),
Angelova-Fischer et al. (2018a,
2018b),
Chang et al. (2018),
Cristaudo et al. (2015),
Korponyai et al. (2016),
Narbutt et al. (2016) and
Weber et al. (2012a, 2012b)
(2) AquaFlux AF200 Danby et al. (2016) and
Theunis et al. (2017)
(3) DermaLab Blaak et al. (2015) and
Blaak et al. (2017)
(4) VapoMeter Brooks et al. (2017) and
Kon et al. (2017)
(7) Skin surface roughness (1) VisioScanVC 98 Angelova-Fischer et al. (2018a)
(2) Visual change in roughness severity (4-point scale: 1 = lack of any change Narbutt et al. (2016)
to 4 = greatest severity changes)
(3) Tactile roughness with a 5-point clinical grading score (0 = absent Weber et al. (2012a, 2012b, 2012c)
(perfectly smooth and pliable) to 4 = extreme (gross irregularly and severe
disturbance of skin markings and definite stiffening))
(8) Skin scaliness/desquamation (1) VisioScanVC 98 Angelova-Fischer et al. (2018a)
(2) Bio-impedance skin analysis device (Hydr8) Federici et al. (2015)
(3) d-Squame® adhesive tapes Chang et al. (2018),
Martini et al. (2017) and
(4) Visual change in severity of desquamation (4-point scale: 1 = lack of any Narbutt et al. (2016)
change to 4 = greatest severity changes)
(9) Stratum corneum cohesion (1) SquamScan 850A Angelova-Fischer et al. (2018a) and
Blaak et al. (2015)
(2) Protein quantification via SquamScan 850A Danby et al. (2016)
(3) Bio-Rad Protein Assay Kit I (Protein amount) Blaak et al. (2015)
(4) Infrared densitometer at wavelength of 850 nm (Absorption) Blaak et al. (2015)
(5) SC Protease activity via tape stripping Danby et al. (2016)
(6) Protein quantity (MMP-1 and filaggrin) via skin biopsy Korponyai et al. (2016)
(10) Visual skin irritation (1) Visual score (according to Frosch and Kligman 1979) Angelova-Fischer et al. (2018b)
(2) Visual change in skin irritation (4-point scale (1 = lack of any change to Narbutt et al. (2016)
4 = greatest severity changes))
(11) Bacterial colonization/skin flora (1) Culture-based microbiological methods (colony-forming units (CFU) per Blaak et al. (2015)
square centimetre of skin)
(2) Skin microbial load via culture media on blood agar and MacConkey agar Paulela et al. (2018)
plates
(12) Stratum corneum recovery rate (1) TEWL measurement 24 h after tape stripping Blaak et al. (2015)
(13) Stratum corneum integrity (1) Tape stripping method (D-Squame Standard) until TEWL increased by Blaak et al. (2015)
3-fold=number of tape strips
(14) Quality of epidermal permeability (1) Lipbarvis analysis: Number of intercellular lipid lamellae Blaak et al. (2017)
barrier (EPB)
(15) Number of lipids (1) High performance thin layer chromatography Blaak et al. (2017)
(16) Skin damage/skin breakdown (1) Degree of skin breakdown via skin assessment: Intact skin or skin Brunner et al. (2012)
breakdown (mild, moderate, severe)
(2) Time to skin breakdown (measurement of minutes and hours) Brunner et al. (2012)
(3) Prevalence of skin damage (any skin abnormalities/lesions; significant Schoonhoven et al. (2015)
skin lesions)
(17) Participant satisfaction (1) Cosmetic acceptability questionnaire (12-item scale) Chang et al. (2018)
(2) 5-point-scale (1 = the lowest satisfaction to 5 = the highest satisfaction) Narbutt et al. (2016)
(18) Safety: adverse events (1) Not defined Chang et al. (2018 ) and
(2) Treatment-related Gin et al. (2017)
Martini et al. (2017)
(19) Incontinence-associated (1) Brownś grading scale (0 = no erythema to 3 = severe erythema) Conley et al. (2014)
dermatitis (2) IADS score (Assessment of erythema, rash, skin loss in 13 areas including Park and Kim (2014)
perianal, perineal, perigenital skin and inner thighs)
(20) Skin redness/erythema (1) Mexameter MX18 Danby et al. (2016)
(2) Erythema index by Photograph color calibration using image editing Kon et al. (2017)
software
(21) PCA (sodium pyrrolidone (1) Tape stripping sampling Danby et al. (2016)
carboxylic acid) and Lactate
(22) Skin sebum content (1) Sebumeter SM 810 Farwick et al. (2014)
Narbutt et al. (2016)
(23) Cutaneous blood microcirculation (1) Flowmeter Periflux PF4001 Farwick et al. (2014)
(24) Skin density/echogenicity (1) Ultrasound scanner, Dermascan C Farwick et al. (2014)
(25) Sagging (1) Expert grading score Farwick et al. (2014)
(26) Quality of life (1) Skindex-16 (Japanese version) 16 items in three scales (symptoms, Izumi et al. (2017)
emotions, functioning)
(27) Pigmentation (1) Melanin index by Photograph color calibration using image editing Kon et al. (2017)
software (Photoshop CS5)
(28) Sulcus cutis thickness (1) Digital image analysis Kon et al. (2017)
(29) Skin friction (1) Frictiometer FR 700 Korponyai et al. (2016)
(30) Skin elasticity (1) Cutometer MPA 580 (R0) Korponyai et al. (2016)
(31) Thickness of epidermis and (1) DUB®-USB high-frequency, high-resolution, ultrasound system Korponyai et al. (2016)
dermis and echogenicity of the
papillary dermis
(32) Pressure ulcer (PU) (1) Incidence of PU stage 2 or higher on application areas sacrum, hips and Lupianez-Perez et al. (2015)
heels
(2) PU incidence Park and Kim (2014) and
Verdu et al. (2012)
(33) Effectiveness due to subject’s (1) 100-mm visual analog scale (VAS) from 0 (not effective/not pleasant) to Martini et al. (2017)
opinion 100 (very effective/very nice)
(34) Skin relief (1) Silicon replicas with image analysis Martini et al. (2017)
(35) Skin auto fluorescence (1) AGE reader Narbutt et al. (2016)
topical applications to prevent pressure ulcers. Based on high qual- Another limitation was the use of a simplified methodolog-
ity evidence only, the review authors concluded that most topi- ical and evidence appraisal system (Oxford Center for Evidence
cal applications showed no benefit or harm (Moore and Webster, Based Medicine, 2009). This approach is clearly limited compared
2018). to the state-of-the art methods for doing systematic reviews focus-
ing on predefined outcomes according to the Cochrane Collabora-
tion (Higgins and Green, 2011) but it does provide a framework to
5. Outcomes evaluate the overall quality of evidence.
The number of 35 different outcome domains and nearly 100 7. Conclusions

outcome measurement instruments was unexpectedly high. The
situation in the field of basic care interventions in the aged is ob- Because of the substantial heterogeneity of study designs, in-
viously similar to many other areas in the field of skin research terventions, skin care products and outcomes a meaningful evi-
(Schmitt et al., 2018). In order to improve the quality of clinical re- dence synthesis is challenging. Basic skin care strategies including
search and systematic reviews we recommend the identification of low-irritating cleansers and humectant-containing leave-on prod-
most relevant outcome domains first, followed by the selection of ucts are helpful for treating dry skin and improving the skin bar-
the best outcome measurement instruments for this domain. Such rier in the aged. Leave-on products with a low pH seem to have an
an initiative has been started for incontinence-associated dermati- additional positive effect on improving the skin barrier. The regular
tis research (Van den Busche et al. 2017; Van den Busche et al. use of leave-on products also seems to prevent skin tear develop-
2018) but is also needed for other areas relevant to nursing prac- ment. Standardized skin care approaches including the application
tice. Given the high prevalence of xerosis cutis in nursing care set- of skin protection products help to prevent incontinence-associated
tings and in particular in the aged (30% to 90%), the high number dermatitis. Therefore we conclude, that the application of leave-on
of clinical studies and the substantial heterogeneity of outcomes products containing basic and common ingredients such as petro-
this is one high priority area. latum, paraffin or glycerin help to maintain skin integrity in this
population. Overall, the quality of evidence is moderate to weak
and in particular, the clinical relevance of differences between skin
6. Limitations
cleansing and caring products is unclear. There is an urgent need
to improve the comparability of skin care product descriptions and
Two major databases, one citation index and numerous refer-
classifications and outcomes in skin care trials.
ence lists were searched, but it is still possible that relevant stud-
ies were not identified. Although RCTs are the reference standard
when investigating treatment effects, we also included a range of Conflict of interest
other study designs providing lower quality evidence. Only seven
high quality RCTs (Federici et al., 2015; Hahnel et al. 2017a, 2017b; None.
Martini et al., 2017, Pham et al. 2011, Quatresooz et al., 2009, Torra
I Bou et al. 2005, Verdu and Soldevilla 2012) were included but Acknowledgments
the results of the weaker study designs were largely comparable.
Our aim was to provide a comprehensive overview of the types of This is an update of a systematic review originally published
available studies, interventions and reported outcomes. Therefore, as Kottner, J., Lichterfeld, A., Blume-Peytavi, U., 2013. Maintaining
broad in- and exclusion criteria were used, because nurses and skin integrity in the aged: a systematic review. British Journal of
other individuals providing skin care need to do the clinical de- Dermatology. 169(3):528-42. doi: 10.1111/bjd.12469.
cisions on a daily basis irrespectively from the availability of high The original review was supported by the Clinical research Cen-
quality evidence. ter for Hair and Skin Science and the update was additionally sup-
In this review, we did not distinguish between evidence of ef- ported by the German Network for Quality Development in Nurs-
fects and effectiveness. It can be assumed that observed effects in ing.
tightly controlled RCTs might not be reproducible in real world sit-
uations. The clinical relevance of chosen treatment durations (e.g. Funding
2 weeks) and outcomes (e.g. transepidermal water loss) is also un-
clear. It can be assumed that properly designed pragmatic RCTs us- This study was supported by the Clinical Research Center for
ing clinical relevant outcomes are more important to inform clini- Hair and Skin Science, the Charité-Universitätsmedizin Berlin and
cal practice. the German Network for Quality Development in Nursing (DNQP)
Supplementary materials Elewa, R., Camera, E., Fluhr, J.W., et al., 2012. Skin quality and stress reaction of
young and old skin can be influenced by skin care products. Exp. Dermatol. 21,
e16 -e7.
Supplementary material associated with this article can be Farwick, M., Kohler, T., Schild, J., Mentel, M., Maczkiewitz, U., Pagani, V., Bonfigli, A.,
found, in the online version, at doi:10.1016/j.ijnurstu.2019.103509. Rigano, L., Bureik, D., Gauglitz, G.G., 2014. Pentacyclic triterpenes from termina-
lia arjuna show multiple benefits on aged and dry skin. Skin Pharmacol. Physiol.
27 (2), 71–81.
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International Journal of Nursing Studies 103 (2020) 103509

Contents lists available at ScienceDirect

International Journal of Nursing Studies

Maintaining skin integrity in the aged: A systematic review

article info abstract

What is already known about the topic?

1. Introduction 2.1. Eligibility criteria

Table 1 study identiﬁcation process, screening and eligibility. One hundred

Fig. 1. Prisma ﬂow chart.

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Outcome domains (what?) Outcome measurement instruments/techniques (how?) References

Outcome domains (what?) Outcome measurement instruments/techniques (how?) References

Outcome domains (what?) Outcome measurement instruments/techniques (how?) References

The number of 35 different outcome domains and nearly 100 7. Conclusions

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