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

Strategic Insights -

A study published in the Annals of Surgical Oncology investigated the effectiveness of a single preoperative dose of antibiotics versus a 7-day postoperative regimen in preventing surgical site infections (SSI) in immediate breast reconstruction following mastectomy. The researchers, led by Brian Gastman from the Cleveland Clinic, conducted a multi-institutional, prospective, randomized controlled trial (RCT) involving 235 women who underwent immediate tissue expander breast reconstruction.

Key Takeaways:

  • The study found that the SSI rate in the single preoperative dose (SPD) arm was 17%, compared to 11% in the 7-day postoperative (WPO) arm, which is within the noninferiority margin set for this study but not significantly noninferior (p = 0.496).
  • The rate of unplanned tissue expander removal for infection, hospitalization rate, and return to OR rate within 30 days of surgery were comparable between the two groups.
  • The study 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.
  • The results have practice-management considerations and may impact clinical guidelines for prophylactic antibiotics in TE-BR procedures.
  • The study was funded by the Plastic Surgery Foundation and had a total of 499 women screened, with 235 enrolled.
  • The SSI rate in the SPD arm was significantly higher than the WPO arm, despite being within the noninferiority margin, indicating that the 7-day postoperative regimen may be more effective.

Statistics:

  • 499 women were screened for the study.
  • 235 women were enrolled in the study.
  • 102 patients were randomized to the SPD arm, and 112 to the WPO arm.
  • 21 patients were withdrawn from the study.
  • The SSI rate in the SPD arm was 17%.
  • The SSI rate in the WPO arm was 11%.
  • The rate of unplanned TE removal for infection was comparable between the two groups.
  • The hospitalization rate within 30 days of surgery was comparable between the two groups.
  • The return to OR rate within 30 days of surgery was comparable between the two groups.

Sources:

  • Antibiotics and Surgical Site Infection in Expander-Based Breast Reconstruction Trial (ASSERT). Annals of Surgical Oncology, 2025. (Springer - www.springer.com; Annals of Surgical Oncology - www.springerlink.com/content/1068-9265/)
  • NewsRx. Researchers from Cleveland Clinic Detail New Studies and Findings in the Area of Medical Devices and Surgical Technology [Antibiotics and Surgical Site Infection in Expander-Based Breast Reconstruction Trial (ASSERT)]. Medical Devices & Surgical Technology Week. November 2, 2025; p 1761.