NCT04731025

Local Antibiotics for Breast Implants

Prophylactic Treatment of Breast Implants With a Solution of Gentamicin, Vancomycin and Cefazolin Antibiotics for Women Undergoing Breast Reconstructive Surgery: a Randomized Controlled Trial (The BREAST-AB Trial)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,003 (estimated)
• Sponsor: Mikkel Herly · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The BREAST-AB Trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.

Detailed description

The BREAST-AB Trial will include women undergoing breast reconstruction with implants. The objective is to determine the efficacy of local antibiotics in decreasing all-cause implant explantation. Participants will be randomized to local application of placebo or gentamicin, vancomycin and cefazolin in a saline solution onto the implant and the dissected breast pocket. All patients undergoing unilateral breast reconstruction will be randomized to the trial drug or placebo in a ratio of 1:1. All patients undergoing bilateral reconstruction will be randomized to the trial treatment on one of their breasts and placebo to the contralateral breast. A total number of 1274 of breasts undergoing breast reconstruction will be included in the trial.

Conditions

• Implant Complication
• Implant Infection
• Implant Site Infection
• Implant Capsular Contracture
• Implant Site Pocket Infection
• Implant Expulsion
• Antibiotic Side Effect

Interventions

Type	Name	Description
DRUG	Gentamicin, Cefazolin and Vancomycin	The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in a 500 mL isotonic saline solution. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.
OTHER	Placebo	500 mL of sterile isotonic (9%) saline. The solution will be used to wash the dissected implant pocket and the implant prior to insertion in the implant pocket.

Timeline

• Start date: 2021-01-27
• Primary completion: 2027-02-01
• Completion: 2027-08-01
• First posted: 2021-01-29
• Last updated: 2026-02-12

Locations

8 sites across 1 country: Denmark