Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

July 25, 2017

Primary Completion Date

September 26, 2018

Study Completion Date

September 26, 2018

Conditions
Breast Implant InfectionMammoplasty
Interventions
OTHER

Normal saline

Intraoperative pocket irrigation with normal saline

DRUG

Cefazolin

Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed

PROCEDURE

Skin biopsy

Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.

PROCEDURE

Bilateral skin- or nipple-sparing mastectomies

Standard of care

DEVICE

Tissue expander

Standard of care

DEVICE

Breast implant

"* Standard of care~* Either breast implant or autologous flap"

PROCEDURE

Autologous flap

"* Standard of care~* Either breast implant or autologous flap"

OTHER

Acellular dermal matrix sling

Standard of care

DRUG

Gentamicin

Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed

DRUG

Bacitracin

Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed

Trial Locations (1)

63110

Washington University School of Medicine, St Louis

All Listed Sponsors
collaborator

The Plastic Surgery Foundation

OTHER

lead

Washington University School of Medicine

OTHER

NCT03213249 - Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy | Biotech Hunter | Biotech Hunter