Surgical Site Infection (SSI) and Antibiotic Use Study
Project Title: A Multi-institutional Randomized Controlled Trial to Determine the Optimal Antibiotic Prophylaxis for Tissue Expander-based Breast Reconstruction
Co-Principal Investigators: Christine Rohde, MD, MPH and Brian Gastman, MD
Coordinating Center: The Plastic Surgery Foundation
Project Description: Surgical Site Infection (SSI) is likely the most common complication in all of surgery, with major consequences to patients' outcomes, as well as contributing to rising healthcare costs. The Centers for Disease Control and Prevention (CDC) recommends a single dose of antibiotics before a surgical procedure for clean cases, even in the presence of a drain, but plastic surgeons often use a longer antibiotic course. This can lead to antibiotic complications and development of resistance.
This study is a prospective, multi-institutional, noninferiority, randomized control trial that will compare the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). The patients will be randomly assigned to one of the two treatment groups. One group will receive a single dose of antibiotics just before surgery and if necessary, more doses during the surgery. The other group will receive the same treatment as the first group, along with an additional week of antibiotics after surgery. The study will assess the rates of SSI from the two groups. It will also assess the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who develop SSIs in each group.
This study is the first interventional, multi-center, randomized control trial ever performed under the auspices of any plastic surgery society. This study will provide direct evidence for the appropriate duration of antibiotics in preventing SSI in implant-based plastic surgical procedures.
- Five U.S. sites will be enrolling patients for this study
- Study set-up is in progress