BACKGROUND: Immobilizing skin microbes is a rational approach to reducing contamination of surgical sites by endogenous microorganisms. METHODS: This randomized, controlled, parallel-group, multicenter, open-label clinical trial (ClinicalTrials.gov NCT00467857) enrolled 300 adults scheduled forelective coronary artery bypass graft surgery. Patients received iodine-based skin preparations followed by a cyanoacrylate-based skin sealant or skin preparations alone. Microbiological samples collected from sternal and graft incision sites immediately before any skin preparation, at the wound border after skin incision, and at the incision after fascial closure were evaluated quantitatively. RESULTS: In evaluable patients, mean microbial counts in collected samples increased at the sternal site after fascial closure compared with after skin incision by 0.37 log10 colony-forming units (CFU)/mL in the skin sealant group (n=120) and by 0.57 log10 CFU/mL in the control group (n=132) (p=0.047, Wilcoxon rank sum test). At the graft site, mean microbial counts increased by 0.09 (n=119) and 0.27 (n=127) log10 CFU/mL, respectively (p=0.037). There was a 35.3% relative risk reduction in surgical site infection (SSI) occurring in the skin sealant group (9 of 146 patients, 6.2%) versus the control group (14 of 147 patients, 9.5%). In obese patients (body mass index [BMI]>30.0 to ≤37.0 kg/m2), the relative risk reduction for SSI associated with skin sealant was 83.3%. CONCLUSIONS: Pretreatment with skin sealant protects against contamination of the surgical incision by migration of skin microbes. Further data are needed to confirm the impact of this technology on SSI rates in clinical practice.
RCT Entities:
BACKGROUND: Immobilizing skin microbes is a rational approach to reducing contamination of surgical sites by endogenous microorganisms. METHODS: This randomized, controlled, parallel-group, multicenter, open-label clinical trial (ClinicalTrials.gov NCT00467857) enrolled 300 adults scheduled for elective coronary artery bypass graft surgery. Patients received iodine-based skin preparations followed by a cyanoacrylate-based skin sealant or skin preparations alone. Microbiological samples collected from sternal and graft incision sites immediately before any skin preparation, at the wound border after skin incision, and at the incision after fascial closure were evaluated quantitatively. RESULTS: In evaluable patients, mean microbial counts in collected samples increased at the sternal site after fascial closure compared with after skin incision by 0.37 log10 colony-forming units (CFU)/mL in the skin sealant group (n=120) and by 0.57 log10 CFU/mL in the control group (n=132) (p=0.047, Wilcoxon rank sum test). At the graft site, mean microbial counts increased by 0.09 (n=119) and 0.27 (n=127) log10 CFU/mL, respectively (p=0.037). There was a 35.3% relative risk reduction in surgical site infection (SSI) occurring in the skin sealant group (9 of 146 patients, 6.2%) versus the control group (14 of 147 patients, 9.5%). In obesepatients (body mass index [BMI]>30.0 to ≤37.0 kg/m2), the relative risk reduction for SSI associated with skin sealant was 83.3%. CONCLUSIONS: Pretreatment with skin sealant protects against contamination of the surgical incision by migration of skin microbes. Further data are needed to confirm the impact of this technology on SSI rates in clinical practice.
Authors: Lindsay M Kuroki; Mary M Mullen; L Stewart Massad; Ningying Wu; Jingxia Liu; David G Mutch; Matthew A Powell; Andrea R Hagemann; Premal H Thaker; Carolyn K McCourt; Akiva P Novetsky Journal: Obstet Gynecol Date: 2017-07 Impact factor: 7.661
Authors: Akiva P Novetsky; Israel Zighelboim; Saketh R Guntupalli; Yevgeniya J M Ioffe; Nora T Kizer; Andrea R Hagemann; Matthew A Powell; Premal H Thaker; David G Mutch; L Stewart Massad Journal: Gynecol Oncol Date: 2014-06-18 Impact factor: 5.482
Authors: Adam J Lorenzetti; Montri D Wongworawat; Christopher M Jobe; Wesley P Phipatanakul Journal: Clin Orthop Relat Res Date: 2013-10 Impact factor: 4.176