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Journal of Visceral Surgery (2018) xxx, xxx—xxx
Available online at
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REVIEW
Skin preparation for abdominal surgery K. Poirot a, B. Le Roy a, L. Badrikian b, K. Slim a,∗ a b
KEYWORDS Surgical site infection; Surgery; Shower; Antisepsis
Service de chirurgie digestive, CHU Clermont-Ferrand, 63003 Clermont-Ferrand, France Service d’hygiène hospitalière, CHU Clermont-Ferrand, 63003 Clermont-Ferrand, France
Summary Introduction: Surgical site infections (SSI) are a public health issue. The purpose of this review is to review the literature on methods of pre-operative skin preparation for the prevention of SSI in abdominal surgery. Methods: In order to obtain the best level of evidence, only meta-analyses and randomized controlled clinical trials were selected from the Cochrane Library and PubMed databases. High-powered non-randomized studies were included when results were not available for the questions asked. The primary endpoint was the rate of SSI within 30 days. Results: Analysis of the 20 selected studies suggested that hair removal in the operative field is not recommended except when it interferes with surgery; in this case, hair clipping or chemical depilation is recommended and shaving should be banned. For the pre-operative shower, the choice of a detergent product with or without antiseptic does not seem to matter, and there were no published data on the required number of showers or the interval before surgery. Application of an alcohol-based solution to the operative field for cutaneous disinfection is recommended; the products used seem to be equivalent, and there is no need for pre-operative detergent scrubbing. There is no strong evidence to recommend adhesive plastic drapes for clean or contaminated surgery. Conclusion: Some recommendations on skin preparation before abdominal surgery to reduce the rate of SSI are based on a high level of evidence. Other recommendations such as the number and duration of pre-operative showers or use of adhesive plastic skin drapes are less well supported. © 2018 Elsevier Masson SAS. All rights reserved.
Introduction Surgical site infections (SSI) remain a public health problem. According to a 2012 national prevalence survey, SSI’s represent 13.5% of nosocomial infections [1]. SSI multiplies the mortality risk by a factor of 4 to 15 and triples the duration
∗ Corresponding author. Service de chirurgie digestive, CHU d’Estaing, 1, place Lucie-Aubrac, 63003 Clermont-Ferrand, France. E-mail address:
[email protected] (K. Slim).
of stay, resulting in an estimated annual cost of 58 million Euros in France and 1.5—19 billion euros in Europe [2]. The rate of SSI in Europe is 9.5% for colonic surgery and 1.4% for cholecystectomy [2]. In the RAISIN network national SSI impact survey published in 2017 [3], the SSI rate was 0.82% for hernia surgery, 0.92% for cholecystectomy, 6.82% for colorectal surgery, and 2.03% for appendectomy. There are three distinct phases in the management of infectious risk in digestive: pre-, per- and post-operative. Skin preparation (SP) is an essential measure in the pre-operative period, and includes a series of measures performed many times a
https://doi.org/10.1016/j.jviscsurg.2018.03.004 1878-7886/© 2018 Elsevier Masson SAS. All rights reserved.
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day in surgery. This literature review tries to answer several questions regarding everyday practices in visceral surgery, based on studies with a high level of evidence: • hair removal: yes or no? By what method? • the pre-operative shower: how many times? With which product? • detergent skin scrub: systematic or not? With which product? • skin disinfection: with which product? • the use of adhesive drapes: yes or no? Impregnated with antiseptic or not?
Methods A systematic search was made in the PubMed and Cochrane Library databases with the following key-words: preoperative shower or bath, chlorhexidine, skin disinfection, pre-operative antisepsis, pre-operative SP, hair removal, adhesive drape. Criteria for study review were high-level evidence-based studies involving abdominal surgery including meta-analyses and randomized controlled trials in which the primary outcome was SSI occurrence. When there were no randomized controlled trials available to answer the questions being posed, we selected non-randomized studies that included more than 1000 patients. Studies for which the primary endpoint was only the bacteriological outcome of SP were not included.
Results We selected twenty studies published between 1971 and 2017 whose primary endpoint was the occurrence of a SSI between 24 hours and 30 days after surgery (Fig. 1).
Hair removal One meta-analysis and one clinical trial were selected [4,5]. The meta-analysis included 14 studies, four of which were excluded because they did not concern abdominal surgery [4]. Among them, a clinical trial dating from 1981[6] included 418 patients divided into three groups: shaving, depilatory cream, or no hair removal; this study found no statistically significant difference between the shaving group versus no hair removal group (RR = 1.59; 95% CI: 0.77—3.27), depilatory cream versus no hair removal (RR = 1.02; (95% CI: 0.45—2.31), and depilatory cream versus shaving (RR1.56; 95% CI: 0.74—3.29) [21]. A 1992 trial [7] compared two groups: shaving versus no shaving, and found no significant difference in SSI. Among the studies published before 1990 comparing shaving versus depilatory cream or hair clipping, none of them showed any statistically significant difference between each group except for the study of Seropian and Reynolds, which found a difference in favor of depilatory cream (RR = 8.83; 95% CI: 1.17—66.47) [8—13] (Table 1). The meta-analysis by Tanner and Norrie [4] concluded that there was no substantial benefit of hair removal on the rate of SSI, but when it became necessary, hair clipping was preferable to shaving. The meta-analysis of Lefebvre et al. [14] included the same studies as the previous one [4], but included a new clinical trial [5] of 156 patients, comparing shaving versus
Figure 1. Flow chart of the literature review (Key-words: skin preparation, visceral surgery, antiseptic, pre-operative shower, hair removal, adhesive drape, surgical site infection).
clipping. and found a statistically significant difference in favor of clipping (SSI rate: 16.7% versus 19.2%). Overall, all eight studies found a significant decrease in SSI rate in favor of clipping (RR = 0.51 95% CI 0.32—0.84).
The pre-operative shower Three meta-analyses were selected [15—17] (Table 2). The last meta-analysis [17] included seven studies [18—24], with a total enrollment of 10,157 patients.
Number of showers No studies in visceral surgery were found with regard to the number of pre-operative showers.
Type of product Chlorhexidine versus detergent solution [17] This meta-analysis included four studies [18—21] and concluded that there was no reduction in the SSI rate with chlorhexidine bath or shower versus shower with simple soap detergent solution (RR = 0.91; 95% CI: 0.80—1.04).
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Skin preparation for abdominal surgery Table 1
3
Results of the studies regarding hair removal.
Author Yes? No? Rojanapirom [7] Court Brown [6]
By what method? Balthazar [8]
Goeau Brissoniere [9] Powis [10]
Seropian [11]
Thorup [12]
Thur de Koos [13]
Taylor [5]
Number of patients
Groups
Results
80 (appendectomy) (A: n = 40, B: n = 40) 418 (abdominal surgery) (A: n = 137, B: n = 126, C: n = 141)
A: shaving, B: no shaving A: shaving, B: depilatory cream, C: no shaving
NS SSI
200 (inguinal hernia repair) (A: n = 100, B: n = 100) 100(elective surgery) (A: n = 51, B: n = 49) 92 (general surgery including abdominal surgery) A: n = 46, B: n = 46) 406 (A: n = 249, B: n = 157) 50 (inguinal hernia repair) (A: n = 24, B: n = 26) 253(general surgery including abdominal surgery) (A: n = 137, B: n = 116) 156 (hernia and varicose vein surgery (A: n = 78, B: n = 78)
A: shaving, B: clipping
NS
A: shaving, B: depilatory cream A: rasage, B: depilatory cream
NS in SSI found
A: shaving, B: depilatory cream
In favor of depilatory cream
A: shaving, B: depilatory cream
NS in SSI
A: shaving, B: depilatory cream
NS
A: shaving, B: clipping
SSI: shaving 15/78, Clipping 13/78
NS
NS
NS: no statistically significant difference; SSI: surgical site infections.
Table 2
Results of studies concerning preoperative shower.
Author
Number of patients
Groups
Results
Chlebicki [16]
16 studies, n = 17,932 (A: 7,952, B: 9,980) 7 studies n = 10,157
A: chlorhexidine; B: other (soap, placebo, no shower) 4 studies n = 7791 (clean or contaminated surgery, vascular surgery: A: chlorhexidine (n = 3,906); B: placebo (n = 3,885) 3 studies (vasectomy, vascular surgery) n = 1443 A: soap (n = 691); B: chlorhexidine (n = 752) 3 studies n = 1142 (vasectomy, plastic surgery, biliary surgery, inguinal hernia, and lung cancer) A: chlorhexidine (n = 623); B: no shower (n = 519)
NS in SSI rate
Webster [17]
NS reduction in SSI risk with chlorhexidine
NS reduction in SSI risk with chlorhexidine
One large study found a statistically significant difference in favor of chlorhexidine, the other studies found NS
NS: no statistically significant difference; SSI: surgical site infections.
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Three studies found no decrease in SSI rate with chlorhexidine (RR = 1.02 95% CI 0.57—1.84) but the I2 statistic for heterogeneity was 60% [19,23,24]. The largest study in terms of number of patients was in 1987 [19] and found a statistically significant decrease in the level of SSI in the chlorhexidine group (RR = 0.70 95% CI 0.51 0.96). However, this study [19] presented methodological flaws including the absence of blinding, and possible performance biases of selection, attribution, and blind randomization. The other two meta-analyses yielded the same result [15,16].
Chlorhexidine shower versus no shower Three studies have compared pre-operative shower with chlorhexidine to no shower, but two of these studies [21,24] did not concern abdominal surgery and found no statistically significant difference in the rate of SSI (RR = 0.82; (95% CI: 0.26—2.62), with an I2 statistic of 70%. A relatively old randomized trial [22] concerning biliary and hernia surgery found a statistically significant decrease in the SSI rate in the group that showered with chlorhexidine (RR = 0.36; 95% CI: 0.17—0.79).
Detergent scrub The meta-analysis [25] included three clinical studies involving 570 patients that compared pre-operative detergent scrub before antiseptic SP versus antiseptic SP alone, and found no significant difference in the rate of SSI between the two groups. A recent non-randomized clinical trial [26] that included 3,924 patients undergoing hernia surgery, divided the patients into two groups: detergent scrub with chlorhexidine (concentration non-specified) versus no detergent scrub. This study found a statistically significantly higher level of SSI in the chlorhexidine detergent scrub group (OR = 1.46; 95% CI: 1.03—2.07) that was confirmed even after adjustment by a propensity score. A randomized clinical trial [27] on abdominal surgery found no statistically significant difference between detergent scrub or no scrub but only included 234 patients without calculating the number of subjects required to detect a statistically significant difference. Fig. 2 diagrammatically illustrates the comparisons made in
Figure 2. Antiseptic and detergent products that have been comparatively evaluated in randomized studies. The comparisons are marked by connecting lines whose thickness indicates the number of comparative studies. The characteristics of the products were not specified in the two studies so they could not be represented in this figure.
the various trials selected in this review. The most commonly evaluated products were povidone/alcohol solution and 0.5% chlorhexidine/alcohol solution.
Abdominal wall skin antisepsis Two meta-analyses and eight clinical trials were selected for review [28—36]. The meta-analysis [28], which included 19 studies published between 2000 and 2014, showed a statistically significant decrease in the rate of SSI (RR = 0.7; 95% CI: 0.36—0.55) with chlorhexidine SP (ranging from 0.5 to 4%) versus aqueous or alcoholic povidone iodine (PVI) in clean and clean contaminated surgery. A 1993 randomized trial [29] of clean and clean-contaminated abdominal surgery revealed no significant difference between one or two applications of skin antisepsis. This study included 135 patients, but no calculation was made of the number of subjects needed for statistical analysis. One clinical trial [30] compared two groups of 50 patients who underwent antiseptic SP with aqueous or alcoholic solutions of PVI for clean hernia surgery; a statistically significant difference was found in favor of antisepsis with alcoholic PVI (P < 0.01). Another trial [31] comparing two groups of 534 patients: one with SP with aqueous 10% PVI preceded by a cutaneous scrub with 7.5% PVI/detergent, the other with 2% aqueous chlorhexidine preceded by cutaneous scrub with 4% chlorhexidine detergent; it found no statistically significant difference in SSI rate (RR = 1.07; (95% CI: 0.52—2.21, P = 0.853). A clinical trial [32] of two groups of 351 patients undergoing clean-contaminated surgery compared SP with 5% PVI versus chlorhexidine (0.5% in 70% alcohol), and reported a difference in favor of chlorhexidine (P = 0.06) that was at the limit of statistical significance. Another trial [33] included 849 patients undergoing clean-contaminated surgery who were divided into two groups: skin scrub and preparation with alcoholic chlorhexidine versus skin scrub and preparation with 10% PVI; a statistically significant decrease in the rate of SSI was found in the chlorhexidine group. A clinical trial [34] that included 388 patients undergoing clean or clean-contaminated surgery was randomized into two groups: chlorhexidine (2% in 70% alcohol) versus 10% PVI; no statistically significant difference was found between the two groups. Another trial [35] compared 205 patients in two groups: PVI 10% versus chlorhexidine (0.5% in 70% alcohol) SP; no statistically significant difference was found between the two groups. A randomized [36] trial of 866 patients undergoing abdominal surgery compared two groups: SP with chlorhexidine (0.5% in 70% alcohol) versus PVI 10%; the rate of SSI was significantly decreased in the chlorhexidine group for clean surgery and biliary tract surgery, but no statistically significant difference was found for patients undergoing hernia surgery, colorectal surgery, or any other laparotomy. A meta-analysis [37] published in 2017 of 6,997 patients in two groups undergoing clean and clean-contaminated surgery compared two groups: aqueous or alcoholic solutions of chlorhexidine versus PVI; a statistically significant decrease in the rate of SSI was found in favor of chlorhexidine (RR = 0.7; (95% CI: 0.60—0.83). Results in Table 3.
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Skin preparation for abdominal surgery Table 3
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Results of studies concerning skin scrubbing and antiseptic skin preparation.
Author
Number of patients
Groups
Results
Author
How many preparations? Lefebvre [25]
2015
7 studies
NS
Prabhu [26]
2016
3924 (inguinal hernia)
Ellenhorn [27]
2005
234 (abdominal surgery) (A: n = 115; B: n = 119)
A: scrubbing plus antiseptic skin prep; B: antiseptic skin prep without scrubbing A: chlorhexidine; B: no chlorhexidine A: scrubbing plus antiseptic skin prep; B: antiseptic skin prep without scrubbing
Antisepsis Srinivas [32]
2014
Park [31]
2016
Privitera [28]
2016
Bibi [34]
2015
Rodrigues [35]
2013
Zhang [37]
2017
351(cleancontaminated surgery) (A: n = 158, B: n = 184) 534 (hepatobiliary and gastrointestinal surgery) (A: n = 267, B: n = 267) 19 studies (clean and clean-contaminated surgery) 388(clean and clean-contaminated surgery) (A: n = 220, B: n = 168) 205(clean and clean-contaminated surgery) (A: n = 102; B: n = 103) 6997
Shirahatti [29]
1993
135 (clean and clean-contaminated surgery) (A: n = 68, B: n = 67)
Djozic [30]
2016
100 (unilateral inguinal hernia) (A: n = 50, B: n = 50)
Berry [36]
1982
866 (clean surgery and biliary tract) (A: n = 453; B: n = 413)
A: chlorhexidine; B: povidone-iodine A: chlorhexidine; B: povidone-iodine
Worse results with chlorhexidine NS
In favor of chlorhexidine but the difference was NS NS
A: chlorhexidine; B: povidone-iodine
In favor of chlorhexidine
A: povidone-iodine; B: chlorhexidine
NS
A: povidone; B: chlorhexidine
NS
A: chlorhexidine; B: povidone-iodine A: 2 pre-draps 10 minutes before operating room; B: 2 pre-draps 2 to 3 minutes before operating room A: 2 draps povidone/alcohol; B: aqueous povidone-iodine A: chlorhexidine; B: povidone-iodine
In favor of chlorhexidine NS
In favor of two draps
In favor of chlorhexidine
NS: no statistically significant difference.
The use of adhesive skin drapes A meta-analysis of seven studies [38] and one randomized trial [39] were selected for review.
Adhesive skin drape not impregnated with antiseptic versus no adhesive skin drape In five studies [40—44] with a total enrollment of 3,082 patients divided into two groups, there was a statistically
significantly higher rate of SSI in the group using adhesive skin drapes (RR = 1.23; (95% CI: 1.02—1.48). Results varied depending on the type of surgery: the RR was 1.37 (95% CI: 0.53—3.53) for clean surgery, 1.24 (95% CI: 0.80—1.92) for clean-contaminated surgery, and 1.03 (95% CI: 0.60—1.75) for contaminated surgery. One clinical trial [39] of 608 patients undergoing upper abdominal surgery, compared two groups: adhesive skin drape versus no adhesive skin drape; a statistically significant decrease in the rate of SSI was found in favor of the use of adhesive drapes (RR = 0.638; (95% CI: 0.429—0.949).
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Adhesive skin drape impregnated with antiseptic versus no adhesive skin drape In the other two studies [45,46], 1,113 patients undergoing clean hernia repair [45] and cardiac surgery [46] were divided into two groups using antiseptic—impregnated adhesive skin drape versus no adhesive skin drape; no statistically significant difference was found between the two groups (RR = 1.03; 95% CI: 0.06—1.66, P = 0.89. The larger study [45] with an enrollment of 1,016 patients found no statistically significant difference between the two groups.
Discussion and conclusions This literature review was conducted according to the precepts of evidence-based medicine and only those publications were retained that could answer the questions posed with a high level of evidence. The following recommendations are based on the data reported in this systematic review and are based on the recommendations of the World Health Organization (WHO) [2] and those of the French Society of Hospital Hygiene (SFHH) [47]. Factual data with a high level of evidence allows a response to some questions but not to others. Systematic hair removal is not recommended, unless the hair interferes with the performance of the procedure. In such cases, it is recommended that hair be removed by clipping or by use of a depilatory cream. Shaving must be prohibited even in the operating room. A pre-operative shower is recommended before both clean and contaminated surgery, but the data from the literature do not allow a high level-of-evidence recommendation for antiseptic soap versus simple soap. There is no evidence that two showers are preferable to a single shower or that a shower on the day of surgery is preferable to a shower the day before. Skin antisepsis with an alcoholic solution is routinely recommended, but detergent scrubbing of the skin prior to antisepsis is not preferable to antiseptic application alone. There does not seem to be any substantial difference between chlorhexidine and PVI. The use of adhesive skin drapes, whether antisepticimpregnated or not, cannot be recommended on a routine basis. The use of non-impregnated adhesive drapes must be prohibited in clean surgery.
Key points • Hair removal is not recommended except when hair will interfere with the surgery. Hair clipping or depilatory cream should be preferred to shaving, which should be avoided in all cases. • Pre-operative showering is recommended before both clean and contaminated surgery, but there are no data from the literature to conclude that any particular antiseptic soap is better than simple detergent soap. There are no conclusive data on the number of pre-operative showers, or the interval prior to the operative procedure
• SP with an alcohol-based antiseptic solution is recommended, but without preference for the type of product (PVI versus chlorhexidine), and detergent skin scrubbing preceding skin antisepsis is probably not essential. • Use of adhesive skin drapes, whether antisepticimpregnated or not, cannot be recommended. For clean surgery, it is recommended to avoid the use of non-impregnated adhesive drapes.
Disclosure of interest KS has given presentations and expert reports for Covidien, Ethicon, Fresenius-Kabi, MSD, Sanofi, and Takeda that have no bearing on the current article. The other authors declare that they have no competing interest.
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Please cite this article in press as: Poirot K, et al. Skin preparation for abdominal surgery. Journal of Visceral Surgery (2018), https://doi.org/10.1016/j.jviscsurg.2018.03.004