NCT03213249已完成1 期
Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of tissue expander(s) removed due to infection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm 1: Intraoperative pocket irrigation with NS
Active Comparator
- 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.
干预措施: Normal saline (Other)
Arm 1: Intraoperative pocket irrigation with NS
Active Comparator
- 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.
干预措施: Skin biopsy (Procedure)
Arm 1: Intraoperative pocket irrigation with NS
Active Comparator
- 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.
干预措施: Bilateral skin- or nipple-sparing mastectomies (Procedure)
Arm 1: Intraoperative pocket irrigation with NS
Active Comparator
- 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.
干预措施: Tissue expander (Device)
Arm 1: Intraoperative pocket irrigation with NS
Active Comparator
- 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.
干预措施: Breast implant (Device)
Arm 1: Intraoperative pocket irrigation with NS
Active Comparator
- 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.
干预措施: Autologous flap (Procedure)
Arm 1: Intraoperative pocket irrigation with NS
Active Comparator
- 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.
干预措施: Acellular dermal matrix sling (Other)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Normal saline (Other)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Cefazolin (Drug)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Skin biopsy (Procedure)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Bilateral skin- or nipple-sparing mastectomies (Procedure)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Tissue expander (Device)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Breast implant (Device)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Autologous flap (Procedure)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Acellular dermal matrix sling (Other)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Gentamicin (Drug)
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
Active Comparator
- 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
干预措施: Bacitracin (Drug)
结局指标
主要结局
Number of tissue expander(s) removed due to infection
时间窗: 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
时间窗: Up to 1 year
次要结局
- 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)
研究者
研究点 (1)
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