Chlorhexidine gluconate-impregnated cloth in prevention surgical site infection: pilot randomized clinical trial

Abstract

Objective: To compare the use of 2% chlorhexidine gluconate-impregnated cloth and 2% liquid chlorhexidine gluconate in the preoperative skin preparation to prevent the occurrence of surgical site infections in patients undergoing clean-contaminated elective surgeries. Methods: Parallel, single-blind, pilot study of the randomized clinical trial (RCT), composed by fortyeight patients underwent clean-contaminated elective surgeries were randomly assigned to the intervention group (n=25, 2% chlorhexidine gluconate-impregnated cloth) and the control group (n=23, pre-operative bathing with 2% liquid chlorhexidine gluconate). The primary outcome was surgical site infection within 30 days after surgery. The patients were instructed to use the products at the night before and at the morning of surgery and received verbal and written instruction on their use. The tests Wilcoxon-Mann-Whitney, Two Sample t-test, Pearson X2 and Fisher's exact tests, risk relative (RR) and 95% confidence interval (CI) were used. The level of significance for all variables was set at α = 5%. Results: 48 patients analyzed, eight (16.7%) developed a surgical site infection. There were no statistically significant differences between the groups regarding the incidence of surgical site infection (RR: 0.92; 95% CI: 0.25-3.25; p=0.898), however there were not cases of superficial incisional surgical site infection in the intervention group. Conclusion: The use of 2% chlorhexidine gluconate-impregnated cloth for preoperative skin preparation did not reveal a statistically significant difference in the prevention of surgical site infection compared to the use of pre-operative bathing with 2% liquid chlorhexidine gluconate.