Single Preoperative Antibiotic Dose vs Week-Long Postoperative Course for SSI Prevention in TE Breast Reconstruction
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Key Takeaway
Consider that evidence for single-dose antibiotic noninferiority in TE-BR is not definitive.
This multi-institutional randomized controlled trial enrolled 214 women aged 18 years or older undergoing immediate tissue expander breast reconstruction (TE-BR) following mastectomy. Patients were randomized to receive either a single preoperative dose (SPD) of antibiotics (n=102) or a 1-week postoperative (WPO) prophylactic antibiotic regimen (n=112). The primary outcome was surgical site infection (SSI) within 30 days, defined by CDC guidelines.
The SSI rate was 17% in the SPD arm compared to 11% in the WPO arm. This 6-percentage-point difference was within the pre-specified noninferiority margin of 6%, but the study did not demonstrate statistical noninferiority (p=0.496). Secondary outcomes, including the rate of unplanned tissue expander removal for infection, hospitalization rate, and return to the operating room within 30 days, were reported as comparable between groups, though specific numbers were not provided. Safety and tolerability data were not reported, and 21 patients were withdrawn from the study.
Key limitations of the evidence were not reported. The study did not definitively demonstrate the noninferiority of a single preoperative dose, nor did it provide evidence that the 1-week postoperative regimen was significantly better. These results have practice-management considerations, but clinicians should interpret them with caution due to the lack of statistical confirmation for noninferiority and the absence of detailed safety and secondary outcome data.
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View Original 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 30 days of surgery were comparable between the two groups.
CONCLUSIONS: 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.
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