This multi-center, prospective randomized controlled trial investigated whether a single preoperative antibiotic dose (SPD) is as effective as a 7-day postoperative (WPO) antibiotic regimen in preventing surgical site infections (SSIs) following immediate tissue expander breast reconstruction (TE-BR) after mastectomy. The study was motivated by the variability in antibiotic prophylaxis practices and the CDC’s guideline recommending a single preoperative dose for clean and clean-contaminated surgeries.
Participants included 235 women aged 18 or older scheduled for immediate TE-BR, randomized into two groups: 102 received only the SPD, while 112 received the standard WPO antibiotics, with some withdrawals. The primary outcome was the incidence of SSI within 30 days, defined by CDC criteria. The trial employed a noninferiority design, with a margin of 6%, to determine if the SPD was not worse than WPO in preventing SSIs.
Results showed that SSI rates were 17% in the SPD group and 11% in the WPO group. While the difference was within the pre-specified noninferiority margin, statistical analysis revealed that the SPD was not significantly noninferior (p = 0.496). Additionally, rates of unplanned tissue expander removal due to infection, hospitalizations, and return to the operating room were similar between groups.
In conclusion, the study did not conclusively establish that a single preoperative antibiotic dose is noninferior to a 7-day postoperative regimen for SSI prevention in immediate TE-BR. Furthermore, there was no significant evidence indicating the superiority of the extended antibiotic course. These findings suggest that a single-dose prophylactic approach may be appropriate, but further research is needed to confirm optimal antibiotic strategies in this setting.
Reference:
Kaur S, Gastman B, Broderick KP, Momoh AO, Phillips BT, Schwarz G, Hanson SE, Hespe GE, Cooney CM, Sommers K, Leu CS, Rohde CH; ASSERT Group. Antibiotics and Surgical Site Infection in Expander-Based Breast Reconstruction Trial (ASSERT). Ann Surg Oncol. 2026 Apr;33(4):3033-3044. doi: 10.1245/s10434-025-18472-6. Epub 2025 Oct 14. PMID: 41085801; PMCID: PMC12982282.
