Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Pain Score
研究概览
简要总结
The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing or portable negative pressure wound dressing is superior in preventing wound complications and infection rates in obese patients undergoing total joint arthroplasty (TJA). Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and analyze the cost benefit of each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those identified at pre-operative testing to have an elevated BMI (> 35)
排除标准
- •Active infection
- •previous scar or wound healing complication
- •post traumatic degenerative joint disease (DJD) with hardware
- •revision surgery
- •inflammatory arthritis
- •anticoagulation outside of the standard of care.
研究组 & 干预措施
Antimicrobial Barrier Dressing
postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7
干预措施: Antimicrobial Barrier Dressing (Combination Product)
Closed-incision Negative Pressure Therapy
portable NPWT device placed in the operating room from surgery to postoperative day 7
干预措施: Negative Pressure Wound Therapy (NPWT) (Device)
结局指标
主要结局
Visual Analog Scale (VAS) Pain Score
时间窗: Day 8
A patient is asked to indicate his/her perceived scar severity along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (worst possible scar) to 100 (best possible scar); the higher the score, the better the scarring.
Wound Evaluation Scale (WES)
时间窗: Day 8
WES is a 6-item scale. Items 1-5 are scored 0 (yes) or 1 (no), and item 6 is scored 0 (poor) or 1 (acceptable). The total score range is 0-6; the higher the score, the more optimal the wound healing.
次要结局
未报告次要终点