Randomized trial of pre-operative Microdacyn versus standard care for prevention of intra-operative wound contamination and post-operative infection in clean surgical procedures

Background: Infections after surgery, especially prosthesis surgery, are uncommon but potentially devastating. The bacteria that cause most of these infections are thought to enter the wound during the operation. Routine peri-operative anti-septic and antibiotic procedures do not eradicate bacteria hiding under the skin surface in hair follicles and sweat glands. These bacteria leak into the wound during the operation. In a randomized, controlled trial 9 months ago (unpublished to date), we found 2 days of pre-operative Microdacyn reduced the quantity of the bacteria that contaminated 'clean' wounds by 80%. We wish to perform this study in a new and larger group of participants undergoing a wider range of surgical procedures and compare different doses and durations of Microdacyn . Protocol: Randomized trial of Microdacyn (3 dose arms) versus standard care for prevention of intraoperative wound contamination in clean surgical procedures Trial sites: Nelson Hospital, and Manuka St Hospital, Nelson 7010 Laboratory: Medlab South, Nelson Hospital, Objectives of the trial To compare the efficacy of additional Microdacyn with standard practices for prevention of intra-operative wound contamination in clean surgery. Trial design: A randomized, unblinded, four-armed, parallel trial of efficacy, including 150 patients. This trial is designed to be run according to the quality standards of Good Clinical Practice and the Declaration of Helsinki for human trials. Primary endpoint 1. Bacterial contamination of intra-operative wound swabs. Secondary endpoints 1. Post-operative wound infection. 2. Treatment-emergent adverse events (TEAE). Hypothesis: Prophylactic treatment with Microdacyn reduces contamination of surgical fields; a longer course of treatment will be more effective than a single dose