Local Antibiotics for Breast Implants

Study Overview
=================
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.

Official Title
-----------------
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)

Conditions
-----------------
Implant Complication, Implant Infection, Implant Site Infection, Implant Capsular Contracture, Implant Site Pocket Infection, Implant Expulsion, Antibiotic Side Effect

Intervention / Treatment
-----------------
* Drug: Gentamicin, Cefazolin and Vancomycin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Biologically female Signed informed consent Scheduled for breast reconstruction with implants or expanders including: Immediate or delayed reconstructions Bilateral or unilateral reconstructions 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Irrigation of implants with sterile isotonic saline<br>The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag. | Other: Placebo<br>* 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.<br>* Other names: Natriumklorid Fresenius Kabi 9 mg-ml;|
| Experimental: Irrigation of implants with a triple antibiotic solution<br>The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline | Drug: Gentamicin, Cefazolin and Vancomycin<br>* 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.<br>* Other names: Hexamycin, Cefazolin MIP and Bactocin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause explantation of the breast implant after the breast reconstruction surgery | 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. | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to explantation (days) | Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery. | 180 days | 
| Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N) | The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment | 180 days | 
| Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N) | The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment | 180 days | 
| Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery | 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. | 180 days | 
| All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery | 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. | 1 year |