A Prospective, Single-arm, Trial to Determine Contamination Rates When Using an Antibacterial Incise Drape During Orthopedic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Evaluation of the presence of contamination at the surgical site during the operative procedure.
研究概览
简要总结
The goal of this clinical study is to generate data on the intended use of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape. The study includes subjects undergoing primary hip or knee arthroplasty procedures.
The study evaluates the intraoperative performance and safety of the incise drape during surgery, including assessment of contamination and operative characteristics.
Participants will have a CHG-impregnated antimicrobial incise drape applied during their surgical procedure. During surgery, samples will be collected from the operative site to assess potential bacterial contamination.
详细描述
This is a prospective, single-arm clinical study conducted in the United States in subjects undergoing primary hip or knee arthroplasty. The study evaluates the intraoperative performance and safety of a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape used during lower extremity orthopedic surgery.
Safety and intraoperative performance outcomes will be assessed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 22 years of age on the day of surgery.
- •Subject is scheduled to undergo a unilateral primary arthroplasty procedure on a hip or knee.
- •Subject is capable of providing informed consent.
- •Subject is willing and able to return for all visits.
排除标准
- •Subject is pregnant or lactating prior to surgery.*
- •*Women who have had surgical sterilization by a medically accepted method (e.g., tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing
- •Subject is scheduled to undergo a lower extremity bilateral arthroplasty procedure.
- •Subject had a previous open knee surgery on the study knee or is scheduled to undergo a revision knee arthroplasty.
- •Subject has had a previous surgery for revision femoral acetabular osteotomy or total hip arthroplasty on the study hip.
- •Subject is scheduled for lower extremity arthroplasty due to trauma.
- •Subject was previously diagnosed with septic arthritis or has a history of infection in the joint.
- •Subject has taken any antibiotics within 4 weeks before surgery.
- •Subject has an allergy or sensitivity to components of the device (e.g., chlorhexidine gluconate or acrylate-based adhesive).
- •Subject is currently enrolled in another trial.
研究组 & 干预措施
Single Treatment Arm
Subjects undergoing primary hip or knee arthroplasty will have a chlorhexidine gluconate (CHG)-impregnated antimicrobial incise drape applied to the surgical site prior to incision and maintained in place for the duration of the surgical procedure.
干预措施: 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (2% w/w CHG) (Device)
结局指标
主要结局
Evaluation of the presence of contamination at the surgical site during the operative procedure.
时间窗: During surgery
Assessment of contamination at the surgical site during the operative procedure.
次要结局
未报告次要终点