Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1003 participants
INTERVENTIONAL
2021-01-27
2026-01-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Irrigation of implants with sterile isotonic saline
The placebo solution will consist of 500 mL of sterile isotonic (9%) saline contained in a infusion bag.
Placebo
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.
Irrigation of implants with a triple antibiotic solution
The antibiotic solution will contain 1000 mg vancomycin, 80 mg gentamicin and 1000 mg cefazolin in 500 mL sterile isotonic (9%) saline
Gentamicin, 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.
Interventions
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Gentamicin, 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.
Placebo
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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University of Copenhagen
OTHER
Herlev and Gentofte Hospital
OTHER
Zealand University Hospital
OTHER
Odense University Hospital
OTHER
Vejle Hospital
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Mikkel Herly
OTHER
Responsible Party
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Mikkel Herly
MD, Ph.d.
Principal Investigators
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Mikkel Herly, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Plastic Surgery and Burns Treatment
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
South-West Jutland Hospital
Esbjerg, , Denmark
Herlev and Gentofte Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Zealand University Hospital
Roskilde, , Denmark
Vejle Hospital
Vejle, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Study protocol published in BMJ Open
Other Identifiers
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2020-002459-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0058322
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
R-189- A4127
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BREAST-AB-01
Identifier Type: -
Identifier Source: org_study_id
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