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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,003
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.
Aalborg University Hospital
Aalborg, Denmark
RECRUITINGAarhus University Hospital
Aarhus, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGSouth-West Jutland Hospital
Esbjerg, Denmark
NOT_YET_RECRUITINGHerlev and Gentofte Hospital
Herlev, Denmark
RECRUITINGOdense University Hospital
Odense, Denmark
RECRUITINGZealand University Hospital
Roskilde, Denmark
RECRUITINGVejle Hospital
Vejle, Denmark
NOT_YET_RECRUITINGAll-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 frame: 180 days
Time to explantation (days)
Time to explantation will be defined as the amount of days between the breast reconstruction and the implant explantation surgery.
Time frame: 180 days
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
Time frame: 180 days
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
Time frame: 180 days
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 frame: 180 days
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.
Time frame: 1 year
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