Evidence-Based Report Card

J Wound Ostomy Continence Nurs. 2018;45(3):265-269.

Published by Lippincott Williams & Wilkins

Does the Use of Clean or Sterile Dressing Technique 1

Affect the Incidence of Wound Infection?
Dea J. Kent ¡ Jody N. Scardillo ¡ Barbara Dale ¡ Caitlin Pike

ABSTRACT
PURPOSE: The purpose of this article is to examine the evidence and provide recommendations for the use of clean or sterile
dressing technique with dressing application to prevent wound infection.
QUESTION: In all persons with acute or chronic wounds, does the use of clean or sterile dressing technique affect incidence of
wound infection?
SEARCH STRATEGY: A search of the literature was performed by a trained university librarian, which resulted in 473 articles that
examined any age group that dealt with application of a wound dressing using either sterile or nonsterile technique. A systematic
approach was used to review titles, abstracts, and text, yielding 4 studies that met inclusion criteria. Strength of the evidence
was rated using rating methodology from Essential Evidence Plus: Levels of Evidence and Oxford Center for Evidence-Based
Medicine, adapted by Gray and colleagues. Johns Hopkins Nursing Evidence-Based Practice Nursing Research Appraisal Tool
was used to rate the quality of the evidence.
FINDINGS: All 4 studies reported no significant difference in the rate of wound infection when using either clean or sterile
technique with dressing application. The strength of the evidence for the identified studies was identified as level 2 (1 level
A, 3 level B). The study sizes were variable, and the wounds included do not represent the continuum of wounds clinically
encountered across the board.
CONCLUSION/RECOMMENDATION: Evidence indicates that the use of clean technique for acute wound care is a clinically
effective intervention that does not affect the incidence of infection. There is no recommendation that can be made regarding
type of dressing technique for a chronic wound due to the lack of evidence in the literature.
KEY WORDS: Acute wound, Bandage, Chronic wound, Clean, Dressing, Incision, Infection, Sterile, Surgical site, Wound.

INTRODUCTION vascular disease that impair healing. These wounds often stall
in one of the healing phases and fail to progress.1
Clinical practice varies widely, and there is little research to
Infection occurs when the presence of bacteria or other
guide the clinician in determining whether clean or sterile
microorganisms that are present in sufficient quantity dam-
technique is more effective in preventing wound infection.
age tissue or impair healing. Common signs and symptoms
A wound is defined as a disruption of the normal function
of infection include purulent exudate, foul odor, erythema,
and structure of the skin and underlying tissue. Acute wounds
warmth, tenderness, edema, pain, fever, and elevated white
usually have an identifiable cause such as trauma or surgery.
blood cell count. When chronic wounds become infected,
They proceed through the healing phases in an orderly, orga-
they may present with subtle signs and symptoms such as in-
nized fashion. Some references use a 4-week time frame on
crease in pain, change in exudate or presence of necrotic tissue,
healing for acute wounds, although there is no consensus.1
delayed healing, poor quality of granulation tissue, unusual
Chronic wounds can begin as an acute wound or result from
odor, or new areas of breakdown. Infection inhibits wound
breakdown of previously intact skin. They are often associated
healing.2
with physiologic conditions such as diabetes and peripheral
Clean dressing technique involves use of a clean procedure
field, clean gloves with sterile supplies, and avoidance of di-
rect contamination of materials and supplies. Sterile technique
Dea J. Kent, DNP, RN, NP-C, CWOCN, QCP, Community Health Network,
Indianapolis, Indiana.
involves use of a sterile procedure field, sterile gloves, sterile
supplies/dressing, and sterile instruments. Meticulous hand
Jody N. Scardillo, DNP, RN, ANP-BC, CWOCN, Albany Medical Center,
Albany, New York.
hygiene is required for both.3
Barbara Dale, BSN, RN, CWOCN, CHHN, COS-C, Quality Home Health,
The purpose of this Evidence-Based Report Card (EBRC) is
Livingston, Tennessee. to examine the evidence and provide recommendations related
Caitlin Pike, MLS, AHIP, IUPUI University Library, Indianapolis, Indiana.
to the use of clean or sterile dressing technique during dress-
The authors have no conflict of interest to disclose.
ing application to prevent wound infection. We developed our
search questions and key words using the PICO model, where
Correspondence: Dea J. Kent, DNP, RN, NP-C, CWOCN, QCP, Community
Health Network, 1500 North Ritter Ave, Indianapolis, IN 46219 (dkent@
P = population, I = intervention, C = comparison, and O =
ecommunity.com). outcome.4
DOI: 10.1097/WON.0000000000000425 P: Persons with acute or chronic wound

Copyright © 2018 by the Wound, Ostomy and Continence Nurses Society™ JWOCN ¡ May/June 2018 265

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266 JWOCN ¡ May/June 2018 www.jwocnonline.com

I: Clean dressing technique of wound infection was compared with uncomplicated

C: Sterile dressing technique lacerations repaired with clean or sterile gloves.5 Another
O: Infection RCT examined wound-healing rates in open surgical wounds
when using sterile or clean technique for dressings.6 The third
Question RCT analyzed infection rates in Mohs Micrographic Surgery
In all persons with acute or chronic wounds, does the use of (MMS) when using clean or sterile gloves during the proce-
clean or sterile dressing technique affect incidence of wound dure.7 The quasi-experimental study considered differences in
infection? infection rates when using clean or sterile dressing technique
with surgical wounds.8 In 3 of 4 studies, there were small sam-
ple sizes. The studies were completed in settings of varying
METHODS/SEARCH STRATEGY sizes. The studies each had different measures to determine
An experienced reference librarian searched 3 multidisciplinary indicators of infection, and there were many types of acute
medical databases on September 21, 2017, to find literature wounds, including lacerations, MMS procedural wound, and
related to clean and sterile dressing technique. The databases a variety of surgical wounds. Studies of clean versus sterile
searched were CINAHL, PubMed, and EMBASE, which were dressing techniques for chronic wound infection rates were
selected for their robust, international scope of available lit- not located.
erature. Search filters for all databases were English language; Using methods described previously,9,10 studies were ap-
article types included were Articles, Articles in Press, and Re- praised and rated for strength (Table 1). Additionally, each
views for EMBASE. Medical Subject Heading (MESH) terms study was assessed for level of recommendation quality using
identified for this search included (dressing* OR bandage*) the Johns Hopkins Nursing Evidence-Based Practice Nursing
AND (wound* OR incision* OR “surgical site*”) AND (clean Research Appraisal Tool (Table 2).11 One study was graded as
OR sterile) AND infection. No date restrictions were made in level A5 and 3 studies as level B.6-8 See Table 3 for a summary
order to capture all relevant literature. of each study.
Following these limiters, 107 results were retrieved from
CINAHL, 339 results were found in EMBASE, and 258 re- Summary of Findings
sults were retrieved from PubMed. A total of 704 article cita- Four studies were identified that met the criteria to answer the
tions were transferred to a proprietary citation management question we posed, and the primary outcome was incidence of
software. After removing duplicate articles across databases, infection of acute and chronic wounds. One RCT by Stotts
473 citations remained for further review. Inclusion criteria and colleagues6 examined the difference between dressing
for the final review were original research studies that were change technique (clean vs sterile) in open abdominal surgi-
English articles on any age group that dealt with application of cal wounds and studied 2 groups of patients for 3 to 9 days
a wound dressing using either sterile or nonsterile technique. postoperatively (n = 30). The 2 groups were randomized into
An initial review of these abstracts removed 457 citations. Of receiving dressing changes 3 times per day, with either clean
the remaining 16, four articles were identified that met all of or sterile technique application, depending upon their group
the inclusion criteria (Figure). assignment. This small study operated on the premise that a
heavy bacterial burden would delay healing and a light bacteri-
al burden stimulates healing. These data showed no significant
FINDINGS difference (P > .5) between the 2 groups on the rate of wound
Four studies were identified that met the inclusion criteria. healing. However, this was a small sample and type II error
Three randomized controlled trials (RCTs) were identified.5-7 (confirms an idea that should have been rejected) could not
One study was quasi-experimental.8 In one RCT, the incidence be ruled out.
Another multicenter RCT by Perelman and colleagues5
studied infection rates in 816 people who had noncompli-
cated traumatic lacerations with surgical repair using sterile
(n = 408) versus nonsterile (n = 408) gloves. There was no
significant difference in the incidence of laceration infection
between these 2 groups (P = .295). The infection rate for the
group that received laceration repair with sterile gloves was
6.1% (95% CI, 3.8-8.4), and the rate in the group that re-
ceived laceration repair with nonsterile gloves was 4.4% (95%
CI, 2.4-6.4). The relative risk of infection was 1.37 (95% CI,
0.75-2.52). Limitations for this study include that an un-
known number of providers performed the laceration repairs,
and the skill levels of the laceration repair provider could have
influenced the outcome (student vs licensed physician, for
example).
The third RCT study by Xia and colleagues7 evaluated
whether there was a difference in infection rates of patient who
underwent MMS in all steps of the procedure with the pro-
viders using either sterile or clean gloves, with 30 subjects in
each group (n = 60). In this study in a single center, a total of
12 wound infections were identified. Two infections occurred
Figure. PRISMA diagram. in the sterile glove group, and 1 infection occurred in the
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JWOCN ¡ Volume 45 ¡ Number 3 Kent et al 267

TABLE 1.
Method for Rating the Strength of the Evidencea
Evidence Level Description
A Evidence based on consistent results of RCTs, other experimental designs, or systematic reviews supported by meta-analysis.
B Evidence based on inconsistent findings from RCTs or evidence based on findings from nonrandomized studies with a control group and/or well-
designed observation (cohort or case-control) studies
C Evidence based on single-group studies, expert consensus or opinion, current or best practice, physiological theory or principles, case series, or case
studies
Abbreviation: RCT, randomized controlled trial.
a
From Gray and colleagues.9 Used with permission.

clean glove group; however, this difference was not statistically expected to cause an infection. Findings from this small study
significant (P = .99). Limitations for this study include a provide preliminary data on clean versus sterile technique and
small sample size. incidence of infection. While gloves are not the only potential
In wounds that heal by secondary intention, a quasi- contaminant for an infection, this study suggests that glove
experimental study done by Lawson and colleagues8 com- types (clean vs sterile) are not a strong factor in the outcome of
pared surgical site infection rates in surgical patients (n = wound infection incidence.12
2033) in their facility. After implementation of nonsterile
wound care for all patients with open surgical wounds, data SORT Statement
were collected for 3 months. Baseline data were also col- The Strength of Recommendation Taxonomy (SORT), devel-
lected for the 3  months prior to the intervention. In the oped by Ebell and colleagues,13 addresses the quality, quantity,
3 months prior to the intervention, the infection rate for and consistency of evidence and allows the rating of bodies of
surgical wounds was 0.84% (n = 1070). After the interven- evidence using a systematic and structured method. Using an
tion, the infection rate for surgical wounds was 0.83% (n adapted version of the SORT methodology described by Gray
= 963). The infection rates in surgical wounds compared and Doughty,14 we accorded the body of evidence related to
pre- and postintervention were not statistically significant. this recommendation as a level 2 to address acute wounds (see
This study has several limitations in that the infection pres- Tables 2 and 3). SORT level 2 is based on results of 1 level A
ence was based on the documentation of a positive wound study or on inconsistent (mixed) findings from 2 or more level
culture. However, it is possible that not all wounds were A studies. We deem level 2 to be acceptable to determine our
cultured and it is also possible that not all wounds were cap- evidence-based recommendation.
tured or identified. The number of wounds counted versus
the number of individual patients counted to produce some Recommendation for Practice
discrepancy cannot be ruled out. The use of clean technique for acute wound care is a clinical-
One important study by Creamer and colleagues12 did ly effective intervention that does not affect the incidence of
not meet the inclusion criteria but is important to mention infection (SORT level 2). However, there are multiple wound
as the investigators studied bacterial load of gloves. This ex- types, and this statement is a recommendation based on scant
cluded study compared the bacterial load of gloves in the 3 literature that does not cover all wound types and clinical sce-
groups of volunteers (n = 25) who (1) donned clean gloves narios. Due to the paucity of scientific evidence available, no
independently, (2) donned sterile gloves independently, and recommendation for technique type for dressings of chronic
(3) donned sterile gloves again with technician assistance. The wounds is made in this EBRC. The literature that is currently
palmar surface of each glove was cultured. While there was available does not support or refute either technique; there-
a significant difference in bacterial load on clean gloves ver- fore, each clinician and setting must establish their own proce-
sus sterile gloves (P < .001), there was a clinically irrelevant dure recommendations for chronic wound care.14
statistical difference when comparing the bacterial contami-
nation on clean gloves with the bacterial load that would be Clinical Implications
Incidence of wound infection in persons with acute or chron-
ic wounds can be affected by 1 or more variables. For this
TABLE 2. EBRC, the evidence for the use of clean versus sterile tech-
Level of Recommendationa nique continues to be controversial in many settings of care.
Level of Recommendation Description A previous JWOCN EBRC of clean versus sterile technique
Level 1 Based on consistent findings from 2 or more when applying dressings14 reported a lack of evidence to
studies with level A evidence support the use of either method for wound care, and only
limited progress has been made to establish firm and broad
Level 2 Based on result of one level A study or incon-
sistent (mixed) findings from 2 or more level
recommendations for acute wounds. The literature is largely
A studies silent on chronic wound infection incidence associated with
sterile or clean dressing technique. Evidence-based practice
Level 3 Based on studies whose highest level of
is defined as a problem-solving approach to clinical deci-
evidence is B
sion-making within a health care organization that integrates
Level 4 Based on level C evidence (expert opinion, case best available scientific evidence and best available experien-
series/case studies, etc) tial (patient and practitioner) evidence, considers internal
a
From Ebell and colleagues13 and Gray and colleagues.9 Used with permission. and external influences on practice, and encourages critical
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268 JWOCN ¡ May/June 2018 www.jwocnonline.com

TABLE 3.
Literature Summary Table
Level of
Evidence Sample/Setting Purpose Findings Limitations
Lawson and colleagues8 B Participants To determine differences in Surgical wounds with sterile Wound cultures may not
Design: Nonrandomized, N = 2033 surgical infection rates and costs dressing technique prior to have been performed on
longitudinal study wounds in total of using sterile vs clean intervention had a 0.84% all patients
Setting: Acute surgical dressing technique in the infection rate Sample size is small
units at a major management of surgical Surgical wounds postintervention May not have had exact
medical center in the wounds (clean technique only) had a number of all surgical
United State 0.83% infection rate, which wounds
was not significant
Perelman and colleagues5 A Participants To determine whether difference There was no significant differ- Sample size in both arms
Design: Prospective, N = 816 patients in the incidence of wound ence in observed infection limited equivalency
randomized, dou- Setting: 3 large commu- infections in uncomplicated rate in uncomplicated lacer- Packaging of different
ble-armed, multicenter nity hospitals in North lacerations varied between ations between patients who gloves allowed for only
study America use of clean vs sterile gloves received repair with clean vs partial blinding to medi-
sterile gloves cal personnel
Ensuing care was not
“absolutely” standardized
Some repairs were
completed by medical
students
Stotts and colleagues6 B Participants To determine if there was a No difference in the wound- Small sample size
Design: 2-group random- N = 30 difference in the rate of healing rate between use of Did not use any empirical
ized study Setting: A hospital in the wound healing and costs of sterile vs clean technique in measure for infection
United States supplies between sterile vs open surgical wounds Type II error may exist
clean dressing technique for Clean technique is less
open surgical wounds expensive
Xia and colleagues7 B Participants To evaluate whether there is No difference in infection rates Small sample size
Design: Prospective, N = 60 a significant difference in when using clean gloves vs
2-arm randomized Setting: An outpatient infection rates in patients sterile gloves during MMS
study clinic in the United undergoing MMS when using wound repairs
States clean vs sterile gloves during
tumor removal/wound repair
phases of the procedure
Abbreviation: MMS, Mohs Micrographic Surgery.

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