Antibiotics and Surgical Site Infection in Expander-Based Breast Reconstruction Trial
Project Title: Antibiotics and Surgical Site Infection in Expander-Based Breast Reconstruction Trial (ASSERT)
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-related complications and the development of antibiotic resistance.
ASSERT is a prospective, multi-institutional, noninferiority, randomized controlled trial (RCT) that compared the efficacy of two antibiotic treatments in preventing SSI in patients receiving immediate breast reconstruction with tissue expanders (TE-BR). The patients were randomly assigned to one of the two treatment groups. One group received a single dose of antibiotics just before surgery, and if necessary, more doses during the surgery. The other group received the same treatment as the first group, along with an additional week of antibiotics after surgery. The study assessed the rates of SSI in the two groups. It also assessed the type, duration and method (oral vs. intravenous) of subsequent antibiotic use for patients who developed SSIs in each group.
This study is the first interventional, multi-center, RCT ever performed under the auspices of any plastic surgery society. Five US centers recruited 235 patients who were randomized to the two study arms. The study findings are published in the Annals of Surgical Oncology.