Reducing Wound Infections Using Bioelectric Wound Dressings
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- AdventHealth
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quantitative bacterial count
研究概览
简要总结
The purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation.
详细描述
The standard of care for enhance recovery after surgery (ERAS) protocol uses chlorhexidine alcohol base prep as the way to clean the skin preoperatively to decrease bacterial flora before sterile prep at the OR.
Under ERAS protocol there is no recommendations on any post-operative dressing. Biolelectric wound dressing has been introduced, used and proof to decrease wound infection in orthopedic extremity clean surgery for years.
The purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective diverticular, benign polyp, or colon cancer resection
- •Age 18-90 years old
- •All patients must receive some kind of bowel prep (SU- prep, pills, Go-Lytely, milk of magnesia, etc.…)
- •Must be off antibiotics for more than 2 weeks before surgery
- •Surgery must be laparoscopic, hand assisted or Robotic
- •Skin will be closed in layers and subcuticular interrupted fashion
- •Just one dose of preoperative antibiotics (Invanz or equivalent if patient is allergic)
- •Patients will have a primary anastomosis, no colostomy.
- •Patient must be compliant with dressing care
- •Ability to provide informed consent
排除标准
- •Active infections before surgery -example: Intra-abdominal abscess not drained or actively on antibiotics on the day of surgery, skin infections
- •Inability to take intestinal bowel preparation
- •Immunosuppression
- •Need of steroid stress dose pre-op
- •Patient receiving active chemotherapy
- •Need of stoma (end ostomies after resection protective stoma included)
- •Need of blood transfusion during surgery
- •Use of irrigation with antibiotics or IRRISEPTR during surgery
- •Any standard contraindication to anesthesia and/or surgery
- •Pregnancy or lactating women
- •Inability to provide informed consent
- •Inability to follow instructions for dressing care
- •Sensitivity or allergy to silver or zinc
研究组 & 干预措施
Control Arm
Study participants will undergo surgery using current ERAS protocol standard of care skin cleaning preparation.
Experimental Arm
Study participants will use Bioelectrical dressing preoperatively and post-operative.
干预措施: Bioelectric dressing (Device)
结局指标
主要结局
Quantitative bacterial count
时间窗: 4 total biopsies will be collected. (3 days before surgery, surgery day pre incision, immediately post-surgery and 3 days post-surgery)
Skin biopsies will be collected and analyzed for bacterial counts
次要结局
未报告次要终点