NCT Number: NCT04731025
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 3
Aalborg University Hospital, Aalborg, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Hexamycin, Cefazolin "MIP" and Bactocin
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: Natriumklorid Fresenius Kabi 9 mg-ml
Time frame: 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.
Time frame: 180 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
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment
Time frame: 180 days
The breast reconstruction surgery will be defined as the surgery where they received the allocated treatment
Time frame: 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.
Time frame: 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.
Time frame: 180 days
Time to discharge will be defined as the amount of days between the breast reconstruction and the day of discharge.
Time frame: 180 days
The breast reconstruction surgery will be defined as the surgery where the patient received the allocated treatment.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Mathilde Hemmingsen, MD
CONTACT
Mikkel Herly, MD, Ph.D.
CONTACT
Mikkel Herly
Other
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)
Acronym: BREAST-AB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06649890
Implant Complication, Implant Infection
Chapel Hill, North Carolina, United States
View Trial DetailsNCT06515886
Bacterial Infections, Bacterial Infections and Mycoses
Montreal, Quebec, Canada
View Trial DetailsNCT03164408
Complication, Postoperative, Implant Complication
View Trial DetailsNCT06038487
Implant Complication
Cleveland, Ohio, United States
View Trial Details