Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
Phase 1
Completed
- Conditions
- MammoplastyBreast Implant Infection
- Interventions
- Other: Normal salineProcedure: Skin biopsyProcedure: Bilateral skin- or nipple-sparing mastectomiesDevice: Breast implantDevice: Tissue expanderProcedure: Autologous flapOther: Acellular dermal matrix sling
- Registration Number
- NCT03213249
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
Breast implants, either cosmetic or reconstructive, are among the most common procedures performed by plastic surgeons. Bacterial infections or biofilms are implicated in the majority of breast implant complications including infection requiring explantation, capsular contracture (CC), and/or breast-implant associated anaplastic large cell lymphoma (BIA-ALCL). The research team, which has already extensively characterized bacterial pathogenesis in the urinary tract and designed non-antibiotic therapeutics to reduce the incidence of catheter-associated urinary tract infections (CAUTIs), and proposal will study bacteria-breast implant interactions and explore further the impact of the breast microbiome. The proposed research provides a greater understanding of which bacteria can colonize breast implants, their source, and how effective antibiotic pocket irrigation is at eliminating them, and begins to examine the mechanisms by which bacteria bind and colonize the implant surface. These insights will set the groundwork for developing new therapeutic agents that can disrupt the binding of certain bacteria to breast implants. Strategies that minimize problems bacteria can cause, while avoiding antibiotics, will reduce bacteria-related implant complications, limit antibiotic-related side effects, and reduce bacterial resistance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 19
Inclusion Criteria
- Female
- Between 18 and 75 years of age, inclusive
- Undergoing bilateral mastectomy reconstruction with tissue expanders (ipsilateral therapeutic/contralateral prophylactic) planned to be exchanged for breast implants
- Able to understand and willing to sign an IRB-approved written informed consent document
Exclusion Criteria
- Male
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Intraoperative pocket irrigation with NS Normal saline * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket. Arm 1: Intraoperative pocket irrigation with NS Breast implant * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket. Arm 1: Intraoperative pocket irrigation with NS Autologous flap * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket. Arm 2: Intraoperative pocket irrigation with NS + antibiotics Bilateral skin- or nipple-sparing mastectomies * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Arm 2: Intraoperative pocket irrigation with NS + antibiotics Tissue expander * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Arm 1: Intraoperative pocket irrigation with NS Bilateral skin- or nipple-sparing mastectomies * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket. Arm 2: Intraoperative pocket irrigation with NS + antibiotics Breast implant * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Arm 1: Intraoperative pocket irrigation with NS Skin biopsy * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket. Arm 1: Intraoperative pocket irrigation with NS Acellular dermal matrix sling * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket. Arm 2: Intraoperative pocket irrigation with NS + antibiotics Normal saline * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Arm 2: Intraoperative pocket irrigation with NS + antibiotics Autologous flap * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Arm 2: Intraoperative pocket irrigation with NS + antibiotics Acellular dermal matrix sling * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Arm 1: Intraoperative pocket irrigation with NS Tissue expander * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket. Arm 2: Intraoperative pocket irrigation with NS + antibiotics Skin biopsy * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Arm 2: Intraoperative pocket irrigation with NS + antibiotics Cefazolin * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Arm 2: Intraoperative pocket irrigation with NS + antibiotics Gentamicin * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Arm 2: Intraoperative pocket irrigation with NS + antibiotics Bacitracin * 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin
- Primary Outcome Measures
Name Time Method Number of tissue expander(s) removed due to infection Up to 1 year The bulk of analyses will be to study bacterial biofilm formation on the explanted breast tissue, skin/scar, drain, acellular dermal matrix, tissue expander, and capsule.
Number of tissue expander(s) removed due to patient preference Up to 1 year
- Secondary Outcome Measures
Name Time Method Incidence of development of an infection or a wound Up to 1 year Duration the drain was in Up to 1 year Duration of implantation Up to 1 year Incidence of capsular contracture Up to 1 year
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States