Antibiotics and Surgical Site Infection in Expander-Based Breast Reconstruction Trial (ASSERT).
rct · Level II
Where this comes from
- Record sourced from PubMed, PMID 41085801.
- Also identified by DOI 10.1245/s10434-025-18472-6 and PMC identifier 12982282.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
Abstract
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. 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%. 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 A total of 102 patients were randomized to the SPD arm and 112 to the WPO arm, with 21 patients withdrawn.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 30 days of surgery were comparable between the two groups. This multi-institutional RCT did not definitively demonstrate that a single preoperative dose of antibiotics is not inferior to a 7-day postoperative antibiotic regimen in preventing SSI in immediate TE-BR; there was also no evidence to support that the 7-day regimen was significantly better. As this represents one of the largest multi-institutional study of its kind, these results have practice-management considerations.
Medical subject headings
- Surgical Wound Infection
- Breast Neoplasms
- Anti-Bacterial Agents
- Antibiotic Prophylaxis
- Mammaplasty
- Mastectomy
- Tissue Expansion Devices
- Tissue Expansion