Local Antibiotics for Breast Implants

Phase 3

Recruiting

• Conditions: Implant Site Infection; Implant Site Pocket Infection; Implant Complication; Implant Infection; Implant Capsular Contracture; Antibiotic Side Effect; Implant Expulsion
• Interventions: Drug: Gentamicin, Cefazolin and Vancomycin; Other: Placebo

• Registration Number: NCT04731025
• Lead Sponsor: Mikkel Herly

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study Start: 2021-01-27
• Study First Posted: 2021-01-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-07-27
• Study Completion: 2026-01-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1003

Inclusion Criteria

• Age ≥ 18 years

• Biologically female

• Signed informed consent

• Scheduled for breast reconstruction with implants or expanders including:

  1. Immediate or delayed reconstructions
  2. Bilateral or unilateral reconstructions
  3. With or without simultaneous flap reconstruction

Exclusion Criteria

• Pregnancy
• Breast feeding
• Known allergy towards Vancomycin, Gentamicin and Cefazolin
• Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
• Known allergy towards neomycin
• Known impaired renal function with GFR < 60 mL/min
• Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
• Myasthenia Gravis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irrigation of implants with a triple antibiotic solution	Gentamicin, Cefazolin and Vancomycin	The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline
Irrigation of implants with sterile isotonic saline	Placebo	The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.

Primary Outcome Measures

Name	Time	Method
All-cause explantation of the breast implant after the breast reconstruction surgery	180 days	All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation.

Secondary Outcome Measures

Name	Time	Method
Time to explantation (days)	180 days	Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery.
Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery	180 days	Surgical site infection will be defined according to the CDC classification of surgical site infetion leading to antibiotic treatment with oral or intravenous antibiotics administered after the surgery.
All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery	1 year	All-cause explantation will be defined as explantation and discarding of the implant. Replacement of an expander with a permanent implant and replacement of a permanent breast implant with a new permanent breast implant due to cosmetic revisions such as asymmetry, implant malposition, change of size or implant rotation will not be counted as an explantation.
Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)	180 days	The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment
Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)	180 days	The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment

Trial Locations

Locations (8)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

South-West Jutland Hospital; 🇩🇰 Esbjerg, Denmark

Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark

Zealand University Hospital; 🇩🇰 Roskilde, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark