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Review article
Approximately 25.2 million inpatient surgical procedures were introduced into the surgical wound intraoperatively.5 Most proce-
performed in the United States in 2002.1 In the same year, almost dures for intraoperative surgical asepsis are designed to minimize
135,000 patients were discharged with a principal diagnosis of cutaneous colonization of the surgical site and intraoperative
postoperative surgical site infection (SSI). The mean length of contamination of the wound to prevent subsequent infection.
hospitalization for these patients was 7.5 days, and the mean Whole-body bathing or showering with an antiseptic agent,
hospital charges were $24,346, resulting in aggregate charges of such as 2% to 4% chlorhexidine gluconate, has been shown to
almost $3.3 billion.2 Patients who develop SSI have longer and reduce bacterial colonization of the skin.6 Studies have shown that
costlier hospitalizations than patients who do not develop such the antibacterial effect of chlorhexidine is cumulative7 and lasts
infections,3 are 60% more likely to spend time in an intensive care longer than that produced by other antiseptic agents.8 Whereas
unit and twice as likely to die, and more than 5 times more likely to some studies have shown that preoperative chlorhexidine showers
be readmitted to the hospital.4 reduce the incidence of SSI,9,10 others have found minimal or no
SSIs following clean surgery are caused in nearly all cases by clinically relevant benet.11-17 We have undertaken a meta-analysis
endogenous organisms colonizing the patients skin and are to systematically review published, controlled, clinical trials eval-
uating use of chlorhexidine baths or showers for prevention of SSI.
0196-6553/$36.00 - Copyright 2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
doi:10.1016/j.ajic.2012.02.014
168 M.P. Chlebicki et al. / American Journal of Infection Control 41 (2013) 167-73
Trials from inception until July 30, 2011, using the following
keywords: chlorhexidine, bath, shower, wash, scrub, disinfection,
preoperative care, perioperative care, surgical site infection, and
surgical wound infection. No language restrictions were applied.
References from articles were reviewed to identify other potentially
relevant articles. Our search strategy and analysis complied with
the Preferred Reporting Items for Systematic Reviews and Meta-
Analyses (PRISMA) statement.18
Prospective randomized controlled trials and quasirandomized
trialsdthose that allocated treatment by day of the week or by
warddas well as before-after trials comparing a preoperative
whole-body chlorhexidine shower or bath with nonantiseptic soap
or no bath and reporting SSI as an outcome were included in our
review. We chose to include quasirandomized trials because these
are common study designs that may yield useful information. Case
reports, abstract-only, review articles, letters, and editorials were
excluded. All authors independently reviewed each report identi-
ed by the search strategy.
Study quality
Statistical analysis
Summary risk ratios (RR) and their 95% condence intervals (CI)
were calculated using the DerSimonian and Laird random-effects
model.20 Heterogeneity was assessed with an I2 statistic, where
0% indicates no heterogeneity, and 100% indicates the highest level
of heterogeneity.21 Sensitivity and subgroup analyses were
performed to analyze sources of heterogeneity. Data analysis was
performed using Cochrane Databases Review Manager 5.1.0
software.19
RESULTS
Study selection
The literature search strategy yielded 857 potential articles. Fig 1. PRISMA ow diagram of search strategy. Figure generated with Review Manager
After screening and reviewing articles, 16 studies met our inclusion 5.19
criteria.9,10,12-17,22-29 The search strategy and reasons for exclusion
are detailed in a PRISMA ow diagram in Figure 1.30
In one of these trials,26 the chlorhexidine group was compared nongermicidal soap (n 5,696) or placebo (n 2,207) or no
with 2 control groups: 1 group that received only a limited, partial preoperative shower/noncompliance with regimen (n 2,077). Six
chlorhexidine body wash and another group that received no studies10,14,15,27-29 had patients bathe as outpatients prior to
shower. We only included the chlorhexidine treatment group and procedure, nine11-13,16,17,22,24-26 had baths or showers as inpatients,
the control group that received no shower in our statistical analysis. and one9 did not specify where the washes took place. There was
considerable interstudy variation in the volume, timing, and/or
Study characteristics number of applications as summarized in Table 1.
In 7 trials,12-14,16,17,22,26 patients had a single preoperative bath.
Eight randomized control trials and 8 quasiexperimental trials Two baths were used in 5 trials,10,15,27-29 and 3 trials9,11,24 evaluated
were identied. The 16 included trials enrolled 17,932 the effect of 3 or more preoperative chlorhexidine baths or
patients6,10,12-17,22,24-29: 7,952 patients received a chlorhexidine showers. One did not specify the regimen.25
shower or bath, and 9,980 patients were allocated to various In all trials using a liquid formulation of chlorhexidine, patients
comparator groups of a preoperative shower or bath with were required to apply the chlorhexidine solution or comparator
M.P. Chlebicki et al. / American Journal of Infection Control 41 (2013) 167-73 169
and then thoroughly rinse it off, without specifying the duration of Stay)32 score > 10 to dene SSI. Murray et al used clinical diagnosis
continuous exposure of the skin to 4% chlorhexidine. Trials using during surgical follow-up without a clear denition of what
chlorhexidine cloths instructed patients to use the product once the constituted SSI.28
night before and once the morning of surgery without rinsing the Ten studies specied the duration of hospital follow-up to
wash off. Sponges or brushes were not used in any of the trials. identify SSI. Four followed patients until discharge from the
Preoperative antibiotic prophylaxis was routinely administered hospital,12,13,17,22 1 followed patients for 7 days,14 1 for 3 weeks,15 1
in 6 trials12,16,17,27-29 but was given to only in 12% of patients in the for 1 month,16 1 for 2 months,28 and 2 for 6 weeks
trial conducted by Rotter et al.15 Ayliffe et al22 and Lynch et al24 postoperatively.10,11
mention that the frequency of antimicrobial prophylaxis was
similar both in treatment and comparator groups, without Study quality
providing data. The use of preoperative antimicrobial prophylaxis
was not mentioned in the remaining 7 trials. Nine of the included studies were determined to have a high risk
of bias stemming from lack of randomization, use of historical
Details of randomization controls, or lack of blinding when diagnosing SSI, and the
remaining 7 studies were classied as low risk. The risk assess-
The highest quality trials performed were a multicenter center, ments of the individual studies are listed in Table 1.
prospective, randomized, double-blind, and placebo-controlled All studies had patients shower or bathe at home or in the
trial by Rotter et al15 and a single center, randomized controlled hospital prior to surgery. Details of the protocols used are available
trial by Veiga et al.16 In both studies, randomization was carried out in Table 1. All provided some instruction about proper bathing
in each participating surgical unit by means of computer-generated technique with chlorhexidine to subjects, but only one29 performed
patient trial numbers, which were attached by manufacturer to the an assessment of compliance, having patients remove stickers from
bottles containing either chlorhexidine or placebo. the chlorhexidine package and afx them to a sheet afrming that
The trial by Lynch et al24 was also prospective, randomized, the product was used.
double-blind, and placebo controlled, but no details of the
randomization procedure were provided. Similarly, Randall et al14 Incidence of SSI
and Earnshaw et al12 did not provide any details of the randomi-
zation scheme. Murray et al28 was randomized and used masked Three trials9,10,26 showed a signicant reduction in incidence of
allocation but did not use an identical placebo. SSI among patients randomized to receive a preoperative chlo-
Wells et al17 used a quasirandomized design in which patients rhexidine shower or bath. Table 2 shows the incidence of SSI in each
were assigned to a chlorhexidine or soap bath by month. In a study study. Figure 2 shows the relative risk of SSI in the 16 included
conducted by Wihlborg,26 participating patients were allocated to trials. Overall, 6.8% (543 of 7,952) of patients developed SSI in the
different wards by the chief surgeon. Finally, the 3 remaining trials chlorhexidine group compared with 7.2% (715 of 9,980) of patients
used a design in which all patients admitted to selected surgical in the comparator groups.
wards were allocated to a chlorhexidine bath or shower group, and The summary RR estimate of patients randomized to preoper-
patients admitted to other wards constituted the control group10,22 ative chlorhexidine showers/baths was 0.90 (95% CI: 0.77-1.05),
with the ward allocations reversed after a specied period of time. failing to reject the null hypothesis (P .19), shown in Figure 2. The
Two studies27,29 used a prospective intervention and historical I2 test for heterogeneity showed low heterogeneity (28%).
controls.
Subgroup and sensitivity analysis
Denitions of SSI
Sensitivity analysis was performed, excluding studies sequen-
The investigators used varying denitions of SSI in their trials tially to determine whether any individual study or subgroup had
(Table 1). Six studies10,14,15,22,27,29 used clinical criteria, such as a disproportional impact on the outcome. Sensitivity analyses did
wound inammation, breakdown, or discharge, to dene SSI. not show signicant impact from any study or subgroup.
Although the trials did not explicitly state so, these criteria are To determine whether there was a differential effect of chlo-
similar to the CDC denition for deep incisional SSI as follows: rhexidine in patients undergoing clean surgery, we analyzed the
Meet[ing] one of the following criteria: infection occurs . . . after ndings in the studies reporting the efcacy of preoperative chlo-
the operative procedure . . . and infection appears to be related to rhexidine showers or baths for prevention of SSI in patients
the operative procedure and involves deep soft tissues (eg, fascial undergoing clean surgery. This subgroup failed to reach the
and muscle layers) of the incision and patient has at least 1 of the threshold for statistical signicance, with whole-body preoperative
following: (1) purulent drainage from the deep incision but not chlorhexidine showering or shower demonstrating no clear benet
from the organ/space component of the surgical site, (2) a deep (RR, 0.88; 95% CI: 0.71-1.09, P .24). I2 value was 38%, indicating
incision spontaneously dehisces or is deliberately opened by moderate heterogeneity. The lack of benet was seen also in
a surgeon and is culture positive or not cultured and has 1 of the contaminated and clean contaminated surgery (RR, 0.94; 95% CI:
following signs or symptoms: fever, or localized pain, or tender- 0.76-1.16, P .55), with low heterogeneity (I2 0%).
ness. A culture negative nding does not meet this criterion. (3) An We conducted an analysis restricted to the high-quality,
abscess or other evidence of infection involving the deep incision is randomized controlled trials.11,12,14-16,24,28 In these, no benet of
found on direct examination during reoperation or by histopatho- perioperative chlorhexidine washing or showering could be
logic or radiologic examination. (4) Diagnosis of a deep incisional demonstrated (RR, 0.99; 95% CI: 0.85-1.16, P .90). Heterogeneity
SSI by a surgeon or attending physician.31 Dimitrov et al,25 Wihl- of these results was low with I2 0%.
borg,26 Earnshaw et al,12 and Wells et al17 dened SSI as purulent We also analyzed the 7 studies in which patients underwent 2 or
wound discharge. Lynch et al24 required the presence of purulent 3 preoperative showers or baths.9-11,15,24,27,29 The use of multiple
discharge and an ASEPSIS (Additional treatment, presence of Serous chlorhexidine baths did not reach statistical signicance, although
discharge, Erythema, Purulent exudate, Separation of the deep there was a trend toward reduction of SSI (RR, 0.79; 95% CI: 0.60-
tissues, the Isolation of bacteria and the duration of inpatient 1.03, P .08).
Table 1
170
Characteristics of the included studies
Chlorhexidine dosing
Authors, year Study design Type of surgery Exclusion criteria Denition of SSI schedule Comparator group (s) Risk of bias
Brandberg et al,9 1979 Prospective Clean (vascular surgery) Not specied Pus collection at surgical Three to 8 chlorhexidine Soap and water wash High
nonrandomized wound site shower-baths prior to
procedure
Ayliffe et al,22 1983 Before/after, two 30-week Clean, CL/CONT, Trauma and emergency Inammation, breakdown Single bath or shower with Nonmedicated bar soap High
periods contaminated surgery or discharge from wound undiluted 4%
chlorhexidine (25 mL) on
the day of or before
operation
Leigh et al,13 1983 Before/after, 2 wards, 4 Clean, CL/CONT, Not stated Not stated Single bath or shower with Non-medicated soap High
months contaminated undiluted 4%
chlorhexidine (supplied
in 250-mL bottle) a few
hours before operation.
ASEPSIS, Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria, and the duration of inpatient Stay; CL, Clean; CONT, contaminated; SSI, surgical site infection.
product rather than a liquid preparation used in the other studies.
Analysis restricted to studies that used the cloth product (n 3) did
High
High
Low
Low
not show a reduction (P .29) in incidence of SSI.
Publication bias
Noncompliance with
Noncompliance with
Publication bias was assessed with a funnel plot (Fig 3).33 This is
consistent with some degree of publication bias.
regimen
regimen
placebo
apply 2% chlorhexidine
apply 2% chlorhexidine
apply 2% chlorhexidine
reddening of skin occurred in 5 patients (0.36%) of the placebo
to the surgical site and
cloths the night before
surgical site.
surgery
DISCUSSION
immunosuppressive
infection at time of
at time of surgery,
surgery
prospective cohort
Nonrandomized
Table 2
Results of the included studies
Duration of follow up Number of patients in Number of SSI in Number of patients in Number of SSI in
Authors, year for determination of SSI chlorhexidine arm chlorhexidine arm (%) comparator arm comparator arm (%)
Brandberg et al,9 1979 Not specied 171 13 (7.6) 170 30 (17.6)
Ayliffe et al,22 1983 Through hospital 2,703 147 (5.4) 2,833 140 (4.9)
discharge
Leigh et al,13 1983 Through hospital 109 12 (11.0) 115 13 (11.3)
discharge
Wells et al,17 1983 Through postoperative 209 11 (5.3) 245 14 (6.7)
day 10 or hospital
discharge
Randall et al,14 1983 Seven days 32 12 (37.5) 62 19 (30.6)
Hayek et al,10 1987 Six-week follow-up 689 62 (9.0) 1,326 163 (12.3)
Dimitrov et al,25 1984 Not specied 57 0 (0) 46 0 (0)
Wihlborg,26 1987 Not specied 541 9 (1.7) 437 20 (4.6)
Rotter et al,15 1988 Three weeks 1,413 37 (2.6) 1,400 33 (2.4)
Earnshaw et al,12 1989 Through hospital 31 8 (25.8) 35 4 (11.4)
discharge
Byrne et al,11 1991 Six-week follow-up 29 2 (6.9) 27 2 (7.4)
Lynch et al,24 1992 Not specied 1,575 225 (14.3) 1,576 241 (15.3)
Veiga et al,16 2009 Thirty days follow-up 50 1 (2) 50 1 (2)
Johnson et al,27 2010 Not specied 157 0 (0) 897 14 (1.6)
Murray et al,28 2011 Two months 50 0 (0) 50 0 (0)
Zywiel et al,29 2011 Not specied 136 0 (0) 711 21 (3.0)
4% chlorhexidine, which might well explain the failure to detect any effect of chlorhexidine showers daily over 5 days and found that, as
benet in the pooled data. the study progressed, ever greater microbial reductions from the
The antibacterial effect of chlorhexidine is cumulative and baseline were achieved vis--vis a cumulative effect. It is very
greatly enhanced by repeated applications. Paulson39 evaluated the plausible that multiple applications of chlorhexidine over several
Fig 2. Number of infections in clean surgery and clean contaminated/contaminated subgroups. When excluding higher risk of bias studies, OR, 0.98 (95% CI: 0.83-1.16)
Figure generated with Review Manager 5 software.19
M.P. Chlebicki et al. / American Journal of Infection Control 41 (2013) 167-73 173
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