RecruitingPhase 3NCT04731025

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)

Sponsor

Mikkel Herly

Enrollment

1,003 participants

Start Date

Jan 27, 2021

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Gentamicin, Cefazolin and Vancomycin and Placebo for people with antibiotic side effect, implant capsular contracture, and other related conditions. The study is currently recruiting participants at 8 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGentamicin, 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.

OTHERPlacebo

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.