Prophylactic Treatment of Breast Implants With Gentamicin, Vancomycin, and Cefazolin Antibiotics for Women Undergoing Breast Reconstruction Surgery: a Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating local antibiotic treatments to reduce the need for implant removal after breast reconstruction surgery in women. This phase 3 trial compares the effect of a triple antibiotic solution versus a placebo on implant explantation rates. The study aims to see if applying gentamicin, vancomycin, and cefazolin directly to the implant and breast pocket lowers complications leading to implant removal. Participants will be randomly assigned to receive either a saline placebo or an antibiotic solution containing gentamicin, vancomycin, and cefazolin applied locally to the breast implant and pocket during surgery. Women having unilateral reconstruction will receive either treatment or placebo, while those with bilateral reconstruction will receive the antibiotic solution on one breast and placebo on the other. The antibiotic or placebo is delivered in a 500 mL saline solution used to wash the implant and pocket before insertion. Throughout the 180-day study period, participants will be monitored for implant removal due to any cause, infections requiring antibiotics, revision surgeries, and implant exchanges. Researchers will track time to explantation and follow up for up to one year to assess long-term outcomes. Safety and effectiveness will be evaluated through clinical assessments and surgical observations during regular follow-up visits.

Local Antibiotics for Breast Implants