Kotaro Yamakado1. 1. Department of Orthopaedics, Fukui General Hospital, Fukui, Japan. Electronic address: yamakadok@gmail.com.
Abstract
PURPOSE: To evaluate the efficacy of application of the 3% hydrogen peroxide (HP)-soaked gauze as an addition to the standard preoperative sterile skin preparation for Cutibacterium acnes suture contamination in arthroscopic rotator cuff repairs. METHODS: A prospective randomized study was undertaken to evaluate 151 consecutive patients undergoing arthroscopic rotator cuff repair. Each shoulder was prepared with 1 of the 2 randomly selected protocols: chlorhexidine alcohol (1% chlorhexidine gluconate in 70% isopropyl alcohol)(control group) and chlorhexidine alcohol with 3% HP (HP-treated group). In the HP-treated group, the 3% HP-soaked gauze was applied over the shoulder for 5 minutes before the application of the chlorhexidine-alcohol. The first cut-tails of the anchor suture after cuff fixation were submitted to aerobic and anaerobic cultures. Patients were clinically evaluated for infection 10 days, 28 days, 3 months, 6 months, and 12 months after surgery. RESULTS: The rate of C acnes-positive cultures was 13.0% (10 of 77 cases) in the control group and 6.8% (5 of 74 cases) in the HP-treated group. The HP-treated group showed a trend of lower C acnes-positive culture rate, which did not reach statistical significance (relative risk, 0.52; 95% confidence interval, 0.19 and 1.45; number needed to treat, 16.1; P = .20). One case of coagulase-negative Staphylococcus (Staphylococcus intermedius) was isolated in the HP-treated group (1 of 74 cases, 1.3%). No other bacteria were isolated. No infections occurred in any of the patients treated in this study during the minimum 3-month follow-up period. One patient in the HP-treated group complained of skin irritation. CONCLUSIONS: The use of a 3% HP-soaked gauze as an addition to the standard preoperative sterile skin preparation for arthroscopic rotator cuff repairs showed only a marginal effect (statistically insignificant) in reducing the C acnes suture contamination rate in the arthroscopic rotator cuff repair patients. LEVEL OF EVIDENCE: I, prospective, randomized trial.
RCT Entities:
PURPOSE: To evaluate the efficacy of application of the 3% hydrogen peroxide (HP)-soaked gauze as an addition to the standard preoperative sterile skin preparation for Cutibacterium acnes suture contamination in arthroscopic rotator cuff repairs. METHODS: A prospective randomized study was undertaken to evaluate 151 consecutive patients undergoing arthroscopic rotator cuff repair. Each shoulder was prepared with 1 of the 2 randomly selected protocols: chlorhexidinealcohol (1% chlorhexidine gluconate in 70% isopropyl alcohol)(control group) and chlorhexidinealcohol with 3% HP (HP-treated group). In the HP-treated group, the 3% HP-soaked gauze was applied over the shoulder for 5 minutes before the application of the chlorhexidine-alcohol. The first cut-tails of the anchor suture after cuff fixation were submitted to aerobic and anaerobic cultures. Patients were clinically evaluated for infection 10 days, 28 days, 3 months, 6 months, and 12 months after surgery. RESULTS: The rate of C acnes-positive cultures was 13.0% (10 of 77 cases) in the control group and 6.8% (5 of 74 cases) in the HP-treated group. The HP-treated group showed a trend of lower C acnes-positive culture rate, which did not reach statistical significance (relative risk, 0.52; 95% confidence interval, 0.19 and 1.45; number needed to treat, 16.1; P = .20). One case of coagulase-negative Staphylococcus (Staphylococcus intermedius) was isolated in the HP-treated group (1 of 74 cases, 1.3%). No other bacteria were isolated. No infections occurred in any of the patients treated in this study during the minimum 3-month follow-up period. One patient in the HP-treated group complained of skin irritation. CONCLUSIONS: The use of a 3% HP-soaked gauze as an addition to the standard preoperative sterile skin preparation for arthroscopic rotator cuff repairs showed only a marginal effect (statistically insignificant) in reducing the C acnes suture contamination rate in the arthroscopic rotator cuff repair patients. LEVEL OF EVIDENCE: I, prospective, randomized trial.