Local Antibiotics for Breast Implants

Implant Complication Clinical Trial

— BREAST-AB  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731025
• Other study ID #: BREAST-AB-01
• Secondary ID: 2020-002459-4000
• Status: Recruiting
• Phase: Phase 3
• Start date: January 27, 2021
• Est. completion date: January 27, 2026

Study information

• Verified date: May 2024
• Source: Rigshospitalet, Denmark
• Contact: Mikkel Herly, MD, Ph.D.
• Phone: +45 27598919
• Email: mikkel.herly[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1003
• Est. completion date: January 27, 2026
• Est. primary completion date: July 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Side Effect
• Communicable Diseases
• Contracture
• Implant Capsular Contracture
• Implant Complication
• Implant Expulsion
• Implant Infection
• Implant Site Infection
• Implant Site Pocket Infection
• Infections

Intervention

Drug:
• Gentamicin, 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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	South-West Jutland Hospital	Esbjerg
Denmark	Herlev and Gentofte Hospital	Herlev
Denmark	Odense University Hospital	Odense
Denmark	Zealand University Hospital	Roskilde
Denmark	Vejle Hospital	Vejle

Sponsors (9)

Lead Sponsor	Collaborator
Mikkel Herly	Aalborg University Hospital, Aarhus University Hospital, Herlev and Gentofte Hospital, Hospital of South West Jutland, Odense University Hospital, University of Copenhagen, Vejle Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time from the breast reconstruction surgery to discharge (days)	Time to discharge will be defined as the amount of days between the breast reconstruction and the day of discharge.	180 days
Other	Re-admission after the breast reconstruction surgery (Y/N)	The breast reconstruction surgery will be defined as the surgery where the patient received the allocated treatment.	180 days
Other	Long term follow-up after 5, 10 and 15 years	Capsular contracture and the Baker classification grade will be obtained from the National Patient Registry and the patients' medical journals after 5, 10 and 15 years. The BREAST-Q questionnaire will be used to assess patient-reported outcomes. The patients will be contacted and asked to fill out the questionnaire with 5 year-intervals after the surgery.	15 years
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study protocol published in BMJ Open