Clinical trial NCT04731025: Local Antibiotics for Breast Implants
Official 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Implant Complication
Implant Infection
Implant Site Infection
Implant Capsular Contracture
Implant Site Pocket Infection
Implant Expulsion
Antibiotic Side Effect
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Herlev and Gentofte Hospital
name: Zealand University Hospital
name: Odense University Hospital
name: Vejle Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Aarhus University Hospital
name: Aalborg University Hospital
First posted: 2021-01-29
Enrollment: 1003
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause explantation of the breast implant after the breast reconstruction surgery
timeFrame: 180 days
Secondary outcomes:
measure: Time to explantation (days)
timeFrame: 180 days
measure: Revision surgery with incision of the fibrous capsule after the breast reconstruction surgery (Y/N)
timeFrame: 180 days
measure: Exchange of permanent implant to expander implant after the breast reconstruction surgery (Y/N)
timeFrame: 180 days
measure: Surgical site infection that leads to antibiotic treatment after the breast reconstruction surgery
timeFrame: 180 days
measure: All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery
timeFrame: 1 year
Other outcomes:
measure: Time from the breast reconstruction surgery to discharge (days)
timeFrame: 180 days
measure: Re-admission after the breast reconstruction surgery (Y/N)
timeFrame: 180 days
measure: Long term follow-up after 5, 10 and 15 years
timeFrame: 15 years
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Esbjerg
country: Denmark
facility: South-West Jutland Hospital
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Department of Plastic Surgery and Burns Treatment
name: Mikkel Herly, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hemmingsen MN, Larsen A, Weltz TK, Orholt M, Wiberg S, Bennedsen AK, Bille C, Carstensen LF, Jensen LT, Bredgaard R, Koudahl V, Schmidt VJ, Vester-Glowinski P, Holmich LR, Sorensen SJ, Bjarnsholt T, Damsgaard T, Herly M. Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: protocol for a randomised, double-blind, placebo-controlled trial (The BREAST-AB trial). BMJ Open. 2022 Sep 17;12(9):e058697. doi: 10.1136/bmjopen-2021-058697.