Implant Complication Clinical Trial
— BREAST-ABOfficial 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)
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.
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 |
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 |
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 |
Denmark,
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 |
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