BREAST-AB: Local Antibiotics for Breast Implants
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: Irrigation of implants with sterile isotonic saline The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag. |
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.
Other Names:
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Experimental: Irrigation of implants with a triple antibiotic solution 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
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 Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
- 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.
Other Outcome Measures
- Time from the breast reconstruction surgery to discharge (days) [180 days]
Time to discharge will be defined as the amount of days between the breast reconstruction and the day of discharge.
- Re-admission after the breast reconstruction surgery (Y/N) [180 days]
The breast reconstruction surgery will be defined as the surgery where the patient received the allocated treatment.
- Long term follow-up after 5, 10 and 15 years [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Biologically female
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Signed informed consent
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Scheduled for breast reconstruction with implants or expanders including:
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Immediate or delayed reconstructions
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Bilateral or unilateral reconstructions
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With or without simultaneous flap reconstruction
Exclusion Criteria:
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Pregnancy
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Breast feeding
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Known allergy towards Vancomycin, Gentamicin and Cefazolin
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Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
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Known allergy towards neomycin
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Known impaired renal function with GFR < 60 mL/min
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Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
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Myasthenia Gravis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Rigshospitalet | Copenhagen | Denmark | 2100 | |
2 | South-West Jutland Hospital | Esbjerg | Denmark | 6700 | |
3 | Herlev and Gentofte Hospital | Herlev | Denmark | 2730 | |
4 | Odense University Hospital | Odense | Denmark | 5000 | |
5 | Zealand University Hospital | Roskilde | Denmark | 4000 | |
6 | Vejle Hospital | Vejle | Denmark | 7100 |
Sponsors and Collaborators
- Mikkel Herly
- University of Copenhagen
- Herlev and Gentofte Hospital
- Zealand University Hospital
- Odense University Hospital
- Vejle Hospital
- Sydvestjysk Hospital
Investigators
- Principal Investigator: Mikkel Herly, MD, Ph.D., Department of Plastic Surgery and Burns Treatment
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BREAST-AB-01
- 2020-002459-40
- 0058322