Background: Clinical infection remains a significant problem in implant-based breast reconstruction and is a physical and emotional strain to the breast reconstruction patient. Bacterial strikethrough of draping and gown material is a likely source of infection. Strategies to reduce infection in implant-based breast reconstruction are essential to improve patient outcomes.
Objective: The aim of this study is to determine if a disposable draping system is superior to reusable draping materials in the prevention of implant-based breast reconstruction infection.
Methods: This single-institution, prospective, randomized, single-blinded, IRB-approved study enrolled women with breast cancer who were eligible for implant-based breast reconstruction. The primary endpoint was clinical infection by postoperative day 30. Secondary endpoints included all other complications encountered throughout the follow-up period and culture data. Demographic data recorded included patient age, body mass index, diabetes, smoking, chemotherapy, radiation, and follow-up. Procedural data recorded included procedure type, procedure length, estimated blood loss, use of acellular dermal matrix, use of muscle flap, and inpatient versus outpatient setting.
Results: From March 2010 through January 2012, 107 women were randomized and 102 completed the study. Five patients were determined not to be candidates for reconstruction after randomization. There were 43 patients in the Reusable Group and 59 patients in the Disposable Group. There were no significant differences in patient demographic data, procedural data, or the type of procedure performed between groups. In the Reusable Group, there were 5 infections (12%) within 30 days compared to 0 (0%) infections in the Disposable Group (P = 0.012). There was no significant difference in secondary complications. There was a trend for positive wound cultures (11% vs. 3%, P = 0.10) and positive drape cultures (17% vs.4%, P = 0.08) in patients with clinical infection. There were no differences in the number of colony-forming units or positive cultures between groups.
Conclusions: Disposable draping material is superior to a reusable draping system in the prevention of clinical infection within the immediate postoperative period. This study did not demonstrate a clear link between intraoperative culture data and the development of clinical infection. A completely disposable gown and draping system is recommended during implant-based breast reconstruction.