Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: a randomized controlled trial (The BREAST-AB trial)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517672-38-00

Acronym

BREAST-AB-01

Enrollment

1003

Registered

2024-09-20

Start date

2024-09-20

Completion date

Unknown

Last updated

2025-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Brief summary

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

Detailed description

Time to explantation (days), 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), 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)

Interventions

DRUGCefazolin Hikma 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung

DRUGCEFAZOLIN

DRUGVANCOMYCIN

DRUGGENTAMICIN

DRUGNatriumklorid Fresenius Kabi 9 mg/ml infusionsvätska

DRUGlösning

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
All-cause explantation of the breast implant within 180 days after the breast reconstruction surgery	—

Secondary

Measure	Time frame
Time to explantation (days), 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), 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)	—

Measure

Time frame

—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026