Antibiotics and Surgical Site Infection in Expander-Based Breast Reconstruction Trial (ASSERT)
Abstract
Background: The use of prophylactic antibiotics following postmastectomy tissue expander breast reconstruction (TE-BR) varies widely. The Centers for Disease Control and Prevention (CDC) recommends a single preoperative antibiotic dose for clean and clean-contaminated procedures. This multi-institutional, prospective, randomized controlled trial (RCT) examined whether the CDC-recommended single preoperative dose (SPD) of antibiotics is not inferior to an additional week of postoperative (WPO) prophylactic antibiotics in preventing surgical site infection (SSI) in immediate TE-BR following mastectomy.
Methods: Women aged ≥ 18 years undergoing immediate TE-BR were randomized to SPD or WPO groups. The primary outcome was SSI by CDC guidelines within 30 days of surgery. The study used a noninferiority trial design to examine whether the test product (single preoperative dose (SPD)) was not worse than the comparator (1 week of postoperative (WPO) prophylactic antibiotics) by more than a set noninferiority margin of 6%.
Results: In total, five participating centers screened 499 women; 235 were enrolled. A total of 102 patients were randomized to the SPD arm and 112 to the WPO arm, with 21 patients withdrawn. The SSI rate in the SPD arm was 17% as compared with 11% in WPO arm, which is within the noninferiority margin set for this study but not significantly noninferior (p = 0.496). The rate of unplanned TE removal for infection, hospitalization rate, and return to OR rate within…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 499 participants or records.
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