Local Antibiotics for Breast Implants
BREAST-AB
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)
4 other identifiers
interventional
1,003
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2021
Longer than P75 for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2021
CompletedStudy Start
First participant enrolled
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
January 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
February 12, 2026
July 1, 2025
6 years
January 26, 2021
February 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Time to explantation (days)
180 days
Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)
180 days
Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)
180 days
Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery
180 days
All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery
1 year
Other Outcomes (3)
Time from the breast reconstruction surgery to discharge (days)
180 days
Re-admission after the breast reconstruction surgery (Y/N)
180 days
Long term follow-up after 5, 10 and 15 years
15 years
Study Arms (2)
Irrigation of implants with sterile isotonic saline
PLACEBO COMPARATORThe placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.
Irrigation of implants with a triple antibiotic solution
EXPERIMENTALThe antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mikkel Herlylead
- University of Copenhagencollaborator
- Herlev and Gentofte Hospitalcollaborator
- Zealand University Hospitalcollaborator
- Odense University Hospitalcollaborator
- Vejle Hospitalcollaborator
- Aarhus University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Esbjerg Hospital - University Hospital of Southern Denmarkcollaborator
Study Sites (8)
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
South-West Jutland Hospital
Esbjerg, 6700, Denmark
Herlev and Gentofte Hospital
Herlev, 2730, Denmark
Odense University Hospital
Odense, 5000, Denmark
Zealand University Hospital
Roskilde, 4000, Denmark
Vejle Hospital
Vejle, 7100, Denmark
Related Publications (1)
Hemmingsen MN, Larsen A, Weltz TK, Orholt M, Wiberg S, Bennedsen AK, Bille C, Carstensen LF, Jensen LT, Bredgaard R, Koudahl V, Schmidt VJ, Vester-Glowinski P, Holmich LR, Sorensen SJ, Bjarnsholt T, Damsgaard T, Herly M. Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: protocol for a randomised, double-blind, placebo-controlled trial (The BREAST-AB trial). BMJ Open. 2022 Sep 17;12(9):e058697. doi: 10.1136/bmjopen-2021-058697.
PMID: 36115667DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikkel Herly, MD, Ph.D.
Department of Plastic Surgery and Burns Treatment
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The trial will be double-blind so that the patients, site investigators and data monitors will be blinded to the allocation. Only the designated nurses and the members of the trial coordinating unit (who provide the randomization number and treatment allocation) are not blinded to the allocation. The unblinded persons will not in any way be part of the treatment, clinical evaluation of outcomes or data assessment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, Ph.d.
Study Record Dates
First Submitted
January 26, 2021
First Posted
January 29, 2021
Study Start
January 27, 2021
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
February 12, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After the end of the trial, the data will become available (Anticipated july 2025)
- Access Criteria
- Researchers and other relevant parties can be granted access to selected anonymized data after publication upon request to the principal-sponsor investigator
The protocol including the statistical analysis plan is published in BMJ Open (doi:10.1136/bmjopen-2021-058697) prior to unblinding. The main article will include the primary and secondary outcomes. The tertiary and long-term outcomes will be included in subsequent articles. The manuscripts will be submitted to peer-reviewed international journals and both positive, negative and inconclusive results will be published. The findings of the trial will be shared with participating sites and presented at national and international conferences. The results will be disseminated to the public but will not be shared directly with participating patients.