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Background <p>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.</p> Methods <p>Women aged ≥ 18&#xa0;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%.</p> Results <p>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 A total of 102 patients were randomized to the SPD arm and 112 to the WPO arm, with 21 patients withdrawn.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 (<i>p </i>= 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.</p> Conclusions <p>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.</p>

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Antibiotics and Surgical Site Infection in Expander-Based Breast Reconstruction Trial (ASSERT)

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年10月14日

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  • Surinder Kaur,
  • Brian Gastman,
  • Kristen P. Broderick,
  • Adeyiza O. Momoh,
  • Brett T. Phillips,
  • Graham Schwarz,
  • Summer E. Hanson,
  • Geoffrey E. Hespe,
  • Carisa M. Cooney,
  • Katie Sommers,
  • Cheng-Shiun Leu,
  • Christine H. Rohde,
  • Surinder Kaur,
  • Katie Sommers,
  • Gina T. McClure,
  • Christine Rohde,
  • Cheng-Shiun Leu,
  • Kristen P. Broderick,
  • Carisa M. Cooney,
  • Rena Atayeva,
  • Jonlin Chen,
  • Salih Colakoglu,
  • Damon S. Cooney,
  • Matthew Heron,
  • Iman Khan,
  • Michele A. Manahan,
  • Lily Mundy,
  • Joseph Josh Puthumana,
  • Waldemar Rodriguez,
  • Gedge D. Rosson,
  • Danielle Sim,
  • Rafael F. Tiongco,
  • Katie Zhu,
  • Adeyiza O. Momoh,
  • Geoffrey Hespe,
  • Jenni Hamill,
  • Paige L. Myers,
  • Jessica Hsu,
  • Theodore Kung,
  • Jeffrey Kozlow,
  • Brett T. Phillips,
  • Geoffroy Sisk,
  • Rebecca Knackstedt,
  • Scott Hollenbeck,
  • Jennifer Gallagher,
  • Lauren DeRuyter,
  • Brian Gastman,
  • Graham Schwarz,
  • Beverly Doyle,
  • Jackson Hanna,
  • Rothy Rim,
  • Sarah Bishop,
  • Risal Djohan,
  • Sarah Block,
  • Rachel Paskert,
  • Kelly Morley,
  • Summer E. Hanson,
  • Kanad Ghosh

摘要

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.