Local Antibiotics for Women Undergoing Breast Reconstruction Surgery with Implants

Phase 3

Not yet recruiting

• Conditions: Infection

• Registration Number: 2024-517672-38-00
• Lead Sponsor: Rigshospitalet

Brief Summary

The BREAST-AB trial is designed to assess the effect of locally applied antibiotics on all-cause loss of the implant after implant-based breast reconstruction. We hypothesise that local application of gentamicin, vancomycin and cefazolin decrease the risk of postoperative clinical infections and thereby reduce the risk of losing the implant to the benefit of women undergoing implant-based breast reconstruction.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-20
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Female
• Target Recruitment: 1003

Inclusion Criteria

Age ≥ 18 years

Biologically female

Signed informed consent

Scheduled for breast reconstruction with implants or expanders including: a. Immediate or delayed reconstructions b. Bilateral or unilateral reconstructions c. 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
All-cause explantation of the breast implant within 180 days after the breast reconstruction surgery		All-cause explantation of the breast implant within 180 days after the breast reconstruction surgery

Secondary Outcome Measures

Name	Time	Method
Time to explantation (days)		Time to explantation (days)
All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery (Y/N)		All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery (Y/N)
Revision surgery with incision of the fibrous capsule within 180 days after the breast reconstruction surgery (Y/N)		Revision surgery with incision of the fibrous capsule within 180 days after the breast reconstruction surgery (Y/N)
Exchange of permanent implant to expander implant within 180 days after the breast reconstruction surgery (Y/N)		Exchange of permanent implant to expander implant within 180 days after the breast reconstruction surgery (Y/N)
Surgical site infection that leads to antibiotic treatment within 180 days after the breast reconstruction surgery (Y/N)		Surgical site infection that leads to antibiotic treatment within 180 days after the breast reconstruction surgery (Y/N)

Trial Locations

Locations (6)

Herlev Hospital; 🇩🇰 Herlev, Denmark

Roskilde Hospital; 🇩🇰 Roskilde, Denmark

Aarhus Universitetshospital; 🇩🇰 Aarhus N, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Odense University Hospital; 🇩🇰 Odense C, Denmark

Rigshospitalet; 🇩🇰 Copenhagen Oe, Denmark

Herlev Hospital

🇩🇰Herlev, Denmark

Lisbet Hölmich

Site contact

27200014

lisbet.rosenkrantz.hoelmich@regionh.dk