Efficacy of Preadmission Theraworx Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Number of Participants That Developed a Surgical Site Infection
研究概览
简要总结
Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes
Study Design: Single center RCT
Sample Size: 500 patients, aged 18+
Objectives: Primary Objectives:
- Monitor for safety and adverse effects.
- Evaluate for differences in peri-operative skin cultures between treatment groups;
- Compare surgical site infection rates between groups.
Secondary Objectives:
- Assess for patient compliance for each different treatment arms.
- Measure patient satisfaction.
- Measure nurse satisfaction.
- Visual assessment of wound healing
Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient between ages 18-64
- •Scheduled and deemed healthy enough to undergo orthopaedic surgery
- •Willing and able to comply with protocol
排除标准
- •Clinical signs of infection
- •Contraindication to CHG or Theraworx
- •Previous allergic reaction to CHG or Theraworx
- •Surgeon's Discretion
研究组 & 干预措施
Theraworx Group
Usual preadmission surgery instructions (shower the night before) plus theraworx skin wipe system use the night before surgery and 1 hour before surgery.
干预措施: Theraworx Bath Wipes (Other)
CHG Group
Usual preadmission surgery instructions (shower the night before) plus chlorhexidine gluconate (CHG) skin wipe system use the night before surgery and 1 hour before surgery.
干预措施: Chlorhexidine Gluconate 2% Wipe (Drug)
结局指标
主要结局
Number of Participants That Developed a Surgical Site Infection
时间窗: Within 1 year of Surgery
Clinical development of a surgical site infection in the postoperative period.
次要结局
- Number of Patients Compliant With the Requirement of Their Study Group(Day before and day of surgery)
研究者
Ashish Shah
Assistant Professor, Department of Orthopaedics
University of Alabama at Birmingham