Abstract
IMPORTANCE: Surgical site infections (SSIs) represent a costly and preventable complication of cutaneous surgery. However, there is a paucity of randomized clinical trials investigating antibiotic prophylaxis for reducing SSIs in skin cancer surgery, and evidence-based guidelines are lacking. Incisional antibiotics have been shown to reduce the rate of SSIs before Mohs micrographic surgery, but this represents a small subset of skin cancer surgery. OBJECTIVE: To determine whether microdosed incisional antibiotics reduce the rate of SSIs before skin cancer surgery. DESIGN, SETTING, AND PARTICIPANTS: In this double-blind, controlled, parallel-design randomized clinical trial, adult patients presenting to a high-volume skin cancer treatment center in Auckland, New Zealand, for any form of skin cancer surgery over 6 months from February to July 2019 were included. Patient presentations were randomized to one of 3 treatment arms. Data were analyzed from October 2021 to February 2022. INTERVENTIONS: Patients received an incision site injection of buffered local anesthetic alone (control), buffered local anesthetic with microdosed flucloxacillin (500 µg/mL), or buffered local anesthetic with microdosed clindamycin (500 µg/mL). MAIN OUTCOMES AND MEASURES: The primary end point was the rate of postoperative SSI (calculated as number of lesions with SSI per total number of lesions in the group), defined as a standardized postoperative wound infection score of 5 or more. RESULTS: A total of 681 patients (721 total presentations; 1133 total lesions) returned for postoperative assessments and were analyzed. Of these, 413 (60.6%) were male, and the mean (SD) age was 70.4 (14.8) years. Based on treatment received, the proportion of lesions exhibiting a postoperative wound infection score of 5 or greater was 5.7% (22 of 388) in the control arm, 5.3% (17 of 323) in the flucloxacillin arm, and 2.1% (9 of 422) in the clindamycin arm (P = .01 for clindamycin vs control). Findings were similar after adjusting for baseline differences among arms. Compared with lesions in the control arm (31 of 388 [8.0%]), significantly fewer lesions in the clindamycin arm (9 of 422 [2.1%]; P < .001) and flucloxacillin (13 of 323 [4.0%]; P = .03) arms required postoperative systemic antibiotics. CONCLUSIONS AND RELEVANCE: This study evaluated the use of incisional antibiotics for SSI prophylaxis in general skin cancer surgery and compared the efficacy of flucloxacillin vs clindamycin relative to control in cutaneous surgery. The significant reduction in SSI with locally applied microdosed incisional clindamycin provides robust evidence to inform treatment guidelines in this area, which are currently lacking. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12616000364471.