Impact of Postoperative Antibiotic Prophylaxis on Surgical Site Infections Rates After Mastectomy with Drains but Without Immediate Reconstruction: A Multicenter, Double-Blinded, Randomized Control Superiority Trial

Abida K. Sattar, Taleaa Masroor, Russell Seth Martins, Nida Zahid, Hania Shahzad, Rufina Soomro, Omema Saleem, Lubna M. Vohra, Sana Zeeshan, Muhammad Areeb Ashfaq, Irum Khan, Rida Nadeem, Nikhat Fatima, Ayisha Afzal Qureshi, Farin F. Amersi, Syed Faisal Mahmood

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Background: There is no consensus on the use of postoperative antibiotic prophylaxis (PAP) after mastectomy with indwelling drains. We explored the utility of continued PAP in reducing surgical site infection (SSI) rates after mastectomy without immediate reconstruction and with indwelling drains. Patients and Methods: A multicenter, two-armed, randomized control superiority trial was conducted in Pakistan. We enrolled all consenting adult patients undergoing mastectomy without immediate reconstruction. All patients received a single preoperative dose of cephalexin within 60 min of incision, and postoperatively were randomized to receive either continued PAP using cephalexin (intervention) or a placebo (control) for the duration of indwelling, closed-suction drains. The primary outcome was the development of SSI within 30 days and 90 days postoperatively. Secondary outcomes included study-drug-associated adverse events. Intention-to-treat analysis was performed using multivariable Cox regression. Results: A total of 369 patients, 180 (48.8%) in the intervention group and 189 (51.2%) in the control group, were included in the final analysis. Overall cumulative SSI rates were 3.5% at 30 days and 4.6% at 90 days postoperatively. PAP was not associated with SSI reduction at 30 (hazard ratio, HR 1.666 [95% confidence interval CI 0.515–5.385]) or 90 (1.575 [0.558–4.448]) days postoperatively, or with study-drug-associated adverse effects (0.529 [0.196–1.428]). Conclusions: Continuing antibiotic prophylaxis for the duration of indwelling drains after mastectomy without immediate reconstruction offers no additional benefit in terms of SSI reduction. There is a need to update existing guidelines to provide clearer recommendations regarding use of postoperative antibiotic prophylaxis after mastectomy in the setting of indwelling drains.

Original languageEnglish
Pages (from-to)5965-5973
Number of pages9
JournalAnnals of Surgical Oncology
Volume30
Issue number10
DOIs
Publication statusPublished - Oct 2023

Keywords

  • Breast surgery
  • Drain
  • Pakistan
  • Postoperative antibiotic prophylaxis
  • Randomized control trial
  • Surgical site infection

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