Phase
Condition
N/ATreatment
Placebo
Gentamicin, Cefazolin and Vancomycin
Clinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years
Biologically female
Signed informed consent
Scheduled for breast reconstruction with implants or expanders including:
Immediate or delayed reconstructions
Bilateral or unilateral reconstructions
With or without simultaneous flap reconstruction
Exclusion
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 disinfectingagents in the breast implant cavity
Myasthenia Gravis
Study Design
Study Description
Connect with a study center
Aalborg University Hospital
Aalborg, 9000
DenmarkSite Not Available
Aalborg University Hospital
Aalborg 2624886, 9000
DenmarkActive - Recruiting
Aarhus University Hospital
Aarhus, 8000
DenmarkSite Not Available
Aarhus University Hospital
Aarhus 2624652, 8000
DenmarkActive - Recruiting
Rigshospitalet
Copenhagen, 2100
DenmarkSite Not Available
Rigshospitalet
Copenhagen 2618425, 2100
DenmarkActive - Recruiting
South-West Jutland Hospital
Esbjerg, 6700
DenmarkSite Not Available
South-West Jutland Hospital
Esbjerg 2622447, 6700
DenmarkSite Not Available
Herlev and Gentofte Hospital
Herlev, 2730
DenmarkSite Not Available
Herlev and Gentofte Hospital
Herlev 2620431, 2730
DenmarkActive - Recruiting
Odense University Hospital
Odense, 5000
DenmarkSite Not Available
Odense University Hospital
Odense 2615876, 5000
DenmarkActive - Recruiting
Zealand University Hospital
Roskilde, 4000
DenmarkSite Not Available
Zealand University Hospital
Roskilde 2614481, 4000
DenmarkActive - Recruiting
Vejle Hospital
Vejle, 7100
DenmarkSite Not Available
Vejle Hospital
Vejle 2610613, 7100
DenmarkSite Not Available

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