Local Antibiotics for Breast Implants (BREAST-AB)

Mikkel Herly

Status and phase: Enrolling; Phase 3

Conditions: Antibiotic Side Effect; Implant Infection; Implant Expulsion; Implant Site Pocket Infection; Implant Complication; Implant Capsular Contracture; Implant Site Infection

Treatments: Drug: Gentamicin, Cefazolin and Vancomycin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04731025

2020-002459-40 (EudraCT Number)

BREAST-AB-01

R-189- A4127 (Other Grant/Funding Number)

0058322 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,003 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,003 participants in 2 patient groups, including a placebo group

Irrigation of implants with sterile isotonic saline

Placebo Comparator group

Description:

The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.

Treatment:

Other: Placebo

Irrigation of implants with a triple antibiotic solution

Experimental group

Description:

The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline

Treatment:

Drug: Gentamicin, Cefazolin and Vancomycin