Local Antibiotics for Breast Implants

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,003

Participants

Timeline

Start Date

January 27, 2021

Primary Completion Date

July 27, 2025

Study Completion Date

January 27, 2026

Conditions
Implant ComplicationImplant InfectionImplant Site InfectionImplant Capsular ContractureImplant Site Pocket InfectionImplant ExpulsionAntibiotic Side Effect
Interventions
DRUG

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.

OTHER

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.

Trial Locations (8)

2100

RECRUITING

Rigshospitalet, Copenhagen

2730

RECRUITING

Herlev and Gentofte Hospital, Herlev

4000

RECRUITING

Zealand University Hospital, Roskilde

5000

RECRUITING

Odense University Hospital, Odense

6700

NOT_YET_RECRUITING

South-West Jutland Hospital, Esbjerg

7100

NOT_YET_RECRUITING

Vejle Hospital, Vejle

8000

RECRUITING

Aarhus University Hospital, Aarhus

9000

RECRUITING

Aalborg University Hospital, Aalborg

All Listed Sponsors
collaborator

University of Copenhagen

OTHER

collaborator

Herlev and Gentofte Hospital

OTHER

collaborator

Zealand University Hospital

OTHER

collaborator

Odense University Hospital

OTHER

collaborator

Vejle Hospital

OTHER

collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

collaborator

Aarhus University Hospital

OTHER

collaborator

Aalborg University Hospital

OTHER

lead

Mikkel Herly

OTHER