ocal Antibiotics for Women Undergoing Breast Reconstruction Surgery with Implants

Phase 1

• Conditions: Implant-based breast reconstruction following mastectomy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2020-002459-40-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-01
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1002

Inclusion Criteria

The patients must fulfill all the following criteria to be eligible for inclusion in the trial:
-Age = 18 years
-Biologically female
-Signed informed consent
-Scheduled for breast reconstruction with implants including immediate/delayed reconstructions and bilateral/unilateral reconstructions

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 702
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

Patients are considered ineligible if any of the following criteria is fulfilled:
-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 < 6 mL/min
-Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity
-Myasthenia Gravis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified