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The Effect of Preoperative Skin Preparation Products on Surgical Site Infection Heather L. Young, Sara Reese, Bryan Knepper, Amber Miller, Cyril Mauffrey and Connie S. Price Infection Control & Hospital Epidemiology / Volume 35 / Issue 12 / December 2014, pp 1535 - 1538 DOI: 10.1086/678601, Published online: 16 January 2015
Link to this article: http://journals.cambridge.org/abstract_S0195941700093942 How to cite this article: Heather L. Young, Sara Reese, Bryan Knepper, Amber Miller, Cyril Mauffrey and Connie S. Price (2014). The Effect of Preoperative Skin Preparation Products on Surgical Site Infection. Infection Control & Hospital Epidemiology, 35, pp 1535-1538 doi:10.1086/678601 Request Permissions : Click here
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infection control and hospital epidemiology
december 2014, vol. 35, no. 12
concise communication
The Effect of Preoperative Skin Preparation Products on Surgical Site Infection Heather L. Young, MD;1 Sara Reese, PhD, CIC;2 Bryan Knepper, MPH, MSc, CIC;2 Amber Miller, MSN, CIC;2 Cyril Mauffrey, MD, FACS, FRCS;3 Connie S. Price, MD1
Skin preparation products contribute to surgical site infection (SSI) prevention. In a case-control study, diabetes was associated with increased SSI (adjusted odds ratio [OR], 5.74 [95% confidence interval (CI), 1.22–27.0]), while the use of chlorhexidine gluconate (CHG) plus isopropyl alcohol versus CHG alone was found to be protective (adjusted OR, 2.64 [95% CI, 1.12–6.20]). Infect Control Hosp Epidemiol 2014;35(12):1535-1538
Surgical site infections (SSIs) are the most common type of healthcare-associated infection in the United States.1 Skin preparation products are important in the prevention of SSI, although controversy remains regarding the product with the best efficacy. In a randomized controlled trial, Darouiche et al2 demonstrated that chlorhexidine gluconate (CHG) plus isopropyl alcohol (IPA) skin preparation is superior to povidone-iodine (PVI) in the prevention of SSI. Similarly, Lee et al3 found CHG-based products to be associated with fewer SSIs than iodine-based products in a meta-analysis. In contrast, a prospective cohort study by Swenson et al4 found iodine povacrylex (IPC) plus IPA to be associated with lower SSI rates than either CHG ⫹ IPA or PVI alone. Finally, Hakkarainen et al5 found no difference in SSI rates in a large prospective cohort of patients who received CHG, CHG ⫹ IPA, PVI, or IPC ⫹ IPA. CHG-based products are utilized at our hospital for the majority of operative procedures. There are 2 CHG-based products available for surgical skin preparation: combined CHG ⫹ IPA (ChloraPrep) and CHG alone (Hibiclens). Industry-sponsored data suggest that CHG ⫹ IPA produces a greater reduction in colony-forming units/cm2 in healthy volunteers than either IPA or CHG alone.6,7 Our institution noted an increase in SSI rates over a 9month period. As a quality improvement initiative, a casecontrol study was performed to evaluate risk factors for SSI. Preliminary data suggested a correlation between skin preparation product and SSI. This study reports the findings of a formal case-control study.
methods Study Design and Population This was a case-control study of patients who underwent a procedure for which active SSI surveillance was performed at an urban public safety net hospital in Denver, Colorado, between January 1, 2013, and September 30, 2013. Active surveillance is performed by trained infection preventionists for breast surgery, colon surgery, craniotomy/craniectomy, herniorrhaphy, hysterectomy, open reduction of fracture, prostate surgery, spinal fusion, total and partial hip arthroplasty, and total and partial knee arthroplasty. SSI was defined by the National Healthcare Safety Network,8 and all SSIs were agreed upon by at least 2 infection preventionists. Postdischarge SSI surveillance was performed by review of inpatient, outpatient, and emergency encounters from the electronic medical record. The majority of patients at this facility obtain all medical care through providers affiliated with the hospital. Case patients were those who developed SSI after a procedure under active surveillance. Patients who underwent hysterectomy and craniotomy/craniectomy were excluded, since IPA-based skin preparation products are not licensed for these procedures. Three control patients were selected by a randomly generated list for each case, matched for time period and procedure type. Skin preparation product was chosen at the attending surgeon’s discretion. Data Collection Infection preventionists retrospectively abstracted variables from the electronic medical record. Variables of interest included diabetes, malignancy, tobacco use, sex, age, trauma as cause for surgery, use of intraoperative blood recycling, wound class, American Society of Anesthesiologists (ASA) score, body mass index, type and duration of surgery, attending surgeon, presence and type of surgical implant, estimated blood loss, product used for skin preparation, perioperative antibiotic choice and timing, use of clippers for hair removal, and postanesthesia care unit arrival temperature. Statistics Descriptive statistics were used to report the frequency of demographic and risk factor variables. The x2, Fisher exact, and Cochran-Mantel-Haenszel tests were used to examine bivariate associations with SSI. Multivariate logistic regression was used to determine independent associations with the development of SSI. Candidate variables included those with P less than .2 in bivariate analysis. All statistics were calculated using SAS (ver. 9.3; SAS Institute). The Colorado Multiple Institutional Review Board deemed this quality improvement study exempt from review.
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with the use of CHG than with CHG ⫹ IPA (unadjusted odds ratio [OR], 1.8 [95% confidence interval (CI), 0.8–3.6]). A multivariate logistic regression was performed using diabetes, skin preparation product, ASA score, increasing age, and female sex (Table 1). Two variables were independently associated with SSI: diabetes (adjusted OR, 5.74 [95% CI, 1.22–27.0]) and the use of CHG for skin preparation (adjusted OR, 2.64 [95% CI, 1.12–6.20]).
results There were 51 patients who developed SSI and 153 matched controls. Thirty-four (67%) cases were incisional SSI, while 17 (33%) were organ-space SSI. Baseline characteristics were similar between cases and controls, with the exception of diabetes being present in more cases (Table 1). Colon procedures comprised the largest percentage of SSI, followed by open reduction of fracture. Intraoperative blood recycling was performed in 3.9% cases and 0.7% of controls (P p .16). CHG was used for skin preparation in 73% of cases and 62% of controls, while CHG ⫹ IPA was used for skin preparation in 27% of cases and 38% of controls. The product used to prepare the surgical field trended toward significance, with more SSI occurring
discussion This study revealed 1 nonmodifiable and 1 modifiable variable to be associated with the presence of SSI. Diabetes is an established risk factor for SSI after multiple surgical procedures, including spinal fusion and breast surgery.9-11
table 1. Select Variables in the Case-Control Study Variable
SSI cases (n p 51)
Sex, female 28 (55) Age, median (IQR), years 53 (40–65) Body mass index, median (IQR) 28 (23–31) Tobacco use 15 (29) Cancer 6 (12) Diabetes 7 (14) Trauma 11 (22) CHG for skin preparation 33 (69) Wound class CO/D 7 (14) ASA score 3–5 35 (70) Appropriate hair removal 10 (20) Placement of orthopedic implant 30 (59) Perioperative antibiotic timing After incision 1 (2) 0–30 minutes before incision 36 (80) 31–60 minutes before incision 6 (13) 160 minutes before incision 2 (4) Appropriate perioperative antibiotic choicea 43 (86) Procedure duration, median (IQR), minutes 120 (80–200) Estimated blood loss, median (IQR), mL3 100 (25–250) Postanesthesia care unit arrival temperature, median (IQR), ⬚C 36.7 (36.2–37.1) Surgical discipline Orthopedics 20 (39) General surgery 14 (27) Neurosurgery 1 (2) Type of surgery Breast 4 (8) Colon 19 (37) Herniorrhaphy 3 (6) Open reduction of fracture 15 (29) Prostate 0 Spinal fusion 6 (12) Hip arthroplasty 2 (4) Knee arthroplasty 0
Uninfected controls (n p 153)
P
59 51 26 43 22 6 46 81 23 86 38 79
(39) (33–61) (23–30) (29) (14) (4) (30) (56) (15) (56) (26) (48)
1 63 7 2 121 107 100
(1) (86) (10) (3) (83) (65–179) (20–300)
.43 .55
36.6 (36.2–37.0)
.90
56 (37) 62 (41) 9 (6) 12 57 9 45 0 18 6 0
.04 .15 .39 1.00 .64 .02 .27 .16 .86 .08 .43 .17 .84
Unadjusted OR
95% CI
1.94
1.02–3.68
1.00 0.79 3.90 0.66 1.70 0.92 1.82
0.50–2.00 0.30–2.08 1.25–12.20 0.31–1.39 0.80–3.59 0.36–2.29 0.92–3.60
Adjusted OR
95% CI
2.08 1.05
0.96–4.47 0.83–1.32
5.74
1.22–27.0
2.64
1.12–6.20
2.15
0.93–4.94
.74 .09 .46 1.00
(8) (37) (6) (29) (12) (4)
note. Data are no. (%), unless otherwise indicated. ASA, American Society of Anesthesiologists; CHG, chlorhexidine gluconate; CI, confidence interval; CO/D, contaminated or dirty wound class; IQR, interquartile range; OR, odds ratio; SSI, surgical site infection. a Appropriateness of perioperative antibiotic choice was determined by the Surgical Core Improvement Project criteria17.
chg ⫹ ipa prevents ssi
This is the first study to demonstrate that CHG ⫹ IPA is associated with fewer SSIs than CHG alone. These results differ from those of previous authors. Hakkarainen et al5 reported that the choice of skin preparation product does not impact SSI rates after colon, bariatric, and other procedures with clean-contaminated wound class. While these authors included SSI detected only during the index hospitalization, we included SSI detected in the 30 or 90 postoperative days, per the National Healthcare Safety Network definition.8 The abbreviated SSI detection period used by Hakkarainen et al5 likely underestimated the number of SSIs and biased their results to the null hypothesis. Because most SSI is associated with the surgical wound, it is logical that decreasing the bacterial colonization around the surgical wound would lower the risk of incisional infection. The mechanism of increased bacterial lysis with the combination of CHG ⫹ IPA may lie in the duration of action. Alcohol reduces bacterial colonization by 2–3 log reductions immediately after application on the skin;12 CHG remains active on the skin for up to 24 hours after application.13 IPA skin preparation products are not without risk. They may be systemically absorbed, and the manufacturer recommends avoiding CHG ⫹ IPA for cases involving open wounds.14 In addition, IPA skin preparations have been associated with operating room fires, particularly if there is an abundance of hair on the surgical field or if IPA is permitted to pool.15,16 For this reason, it is recommended that IPA dry for at least 3 minutes before making a surgical incision. While some surgeons report that this duration is already spent draping the patient and performing a time out, others consider this to be unacceptably long. Strengths of this study are the inclusion of varying wound classes and different types of surgical procedures, including those with orthopedic implants. Limitations include the retrospective design and small sample size. An additional limitation is that the technique of personnel performing the skin preparation was not assessed. CHG ⫹ IPA is contained within a single applicator sponge; in contrast, CHG is emptied from a multiuse bottle into a sterile container and applied with separate sponges. It is possible that the single applicator sponge was easier to appropriately apply and thus yielded fewer SSIs. Because of this investigation, this institution encourages CHG ⫹ IPA over CHG for appropriate cases. The products have similar cost, and we suspect that application of CHG ⫹ IPA is easier. Further work must be done to determine whether the product combination or simpler applicator technique is responsible for the observed difference.
acknowledgments Potential conflicts of interest. All authors report no conflicts of interest relevant to this article. All authors submitted the ICMJE Form for Disclosure
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of Potential Conflicts of Interest, and the conflicts that the editors consider relevant to this article are disclosed here. Affiliations: 1. Division of Infectious Diseases, Denver Health Medical Center and University of Colorado Denver, Denver, Colorado; 2. Department of Patient Safety and Quality, Denver Health Medical Center, Denver, Colorado; 3. Department of Orthopedic Surgery, Denver Health Medical Center and University of Colorado Denver, Denver, Colorado. Address correspondence to Heather L. Young, MD, Denver Health Medical Center, 660 Bannock Street, MC 4000, Denver, CO 80204 (heather.young2@ dhha.org). Received June 4, 2014; accepted August 5, 2014; electronically published November 7, 2014. 䉷 2014 by The Society for Healthcare Epidemiology of America. All rights reserved. 0899-823X/2014/3512-0014$15.00. DOI: 10.1086/678601
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15. Weber SM, Hargunani CA, Wax MK. DuraPrep and the risk of fire during tracheostomy. Head Neck 2006;28:649–652. 16. Kim JB, Jung HJ, Im KS. Operating room fire using an alcoholbased skin preparation but without electrocautery. Can J Anaesth 2013;60:413–414. 17. Joint Commission. Specifications Manual for Joint Commission National Quality Core Measures (2010B). Oak Brook, IL: Joint Commission, 2010. https://manual.jointcommission.org/releases /archive/TJC2010B1/ProphylacticAntibioticRegimenSelectionFor Surgery.html. Accessed July 16, 2014.