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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

  • Breast Oncology
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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.


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]).


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.

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Data Availability

The data that support the findings of this study are available on request from the corresponding author. The data is not publicly available due to privacy or ethical restrictions.


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The authors would like to acknowledge Dr. Saeed Sadiq Hamid (Director, Clinical Trials Unit, Aga Khan University), Ms. Dilshad Begum (Assistant Manager, Clinical Trials Unit, Aga Khan University), and the support staff at the Clinical Trials Unit, Aga Khan University.


The study received intramural funding (Dean’s fund and Department of Surgery fund).

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Authors and Affiliations



AKS, NZ, HS, RS, OS, FA, and SFM were involved in the conception and design of the study. HS, MAA, LV, SZ, IK, RN, NF, AAQ, TM, and RSM were involved in the implementation of the study protocols and the acquisition of data. RSM and NZ were involved in the analysis of data. The manuscript was drafted by RSM and TM, and critically reviewed by all authors for important intellectual content. AKS was involved in all aspects from conception and design, through implementation, monitoring, internal audits, study coordination, data analysis, manuscript concept, and critical review. All authors approved the final version to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Abida K. Sattar MD, FACS.

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None of the authors have any conflict of interest to declare.

Ethics Approval

This study was performed in line with the principles of the Declaration of Helsinki. Ethics approval was received from the institutional review boards of the three participating hospitals.

Consent to Participate

An informed consent was obtained from all potential participants prior to administration of the survey.

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The informed consent obtained also requested potential participants for their consent to publish results from their survey responses.

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Sattar, A.K., Masroor, T., Martins, R.S. et al. 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. Ann Surg Oncol 30, 5965–5973 (2023).

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