Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Mean Wound Healing Scores by the ASEPSIS Criteria
研究概览
简要总结
For the target population of adult patients following primary total hip arthroplasty, the randomized clinical trial will be used to evaluate the efficacy of the use of a mobile negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in the immediate postoperative period. We will apply two dressing types and evaluate the postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple variables of wound infection risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing primary total hip arthroplasty.
排除标准
- •age less than 18 y/o
- •Total hip arthroplasty for fracture
- •Revision or conversion total hip arthroplasty
- •inability to personally consent to participation due to cognitive impairment, intoxication or sedation
- •multiple surgical procedures
- •Patients taking immune modulating medication(prednisone, methotrexate, anakinra, etc.)
- •skin hypersensitivity to acrylic adhesive or silver.
- •Inability to care for dressing due to physical or mental incapacitation
研究组 & 干预措施
Standard group
Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
PREVENA Group
Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.
干预措施: PREVENA (Device)
结局指标
主要结局
Mean Wound Healing Scores by the ASEPSIS Criteria
时间窗: (Single point evaluation)-2 weeks post surgery visit
A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale.
次要结局
- Number of Participants With Infection((Single point evaluation)-6 weeks post surgery visit)