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.
Age ≥ 18 years
Biologically female
Signed informed consent
Immediate or delayed reconstructions
Pregnancy
Breast feeding
Known allergy towards Vancomycin, Gentamicin and Cefazolin
Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides
Parallel
Gentamicin, Cefazolin and Vancomycin
DrugThe 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.
Placebo
Other intervention500 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.
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.
Time to explantation (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)
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)
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
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.
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.
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.
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.
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Mikkel Herly
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
University of Copenhagen
Collaborator
Herlev and Gentofte Hospital
Collaborator
Zealand University Hospital
Collaborator
Odense University Hospital
Collaborator
Vejle Hospital
Collaborator
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborator
Aarhus University Hospital
Collaborator
Aalborg University Hospital
Collaborator
