Antibiotic Side Effect, Implant Capsular Contracture, Implant Complication, Implant Expulsion, Implant Infection, Implant Site Infection, Implant Site Pocket Infection
Conditions
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.
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.
Interventions
DRUGGentamicin, 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.
OTHERPlacebo
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.
Sponsors
Herlev and Gentofte Hospital
Zealand University Hospital
Odense University Hospital
Vejle Hospital
Esbjerg Hospital - University Hospital of Southern Denmark
Aarhus University Hospital
Aalborg University Hospital
Mikkel Herly
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORMikkel Herly, MD, Ph.D.
Department of Plastic Surgery and Burns Treatment
Outcome results
None listed