跳至主要内容
临床试验/NCT06181097
NCT06181097招募中不适用

Routine Use of Negative Pressure Wound Therapy in Primary Hip and Knee Arthroplasties; a Randomized Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2023年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
82
试验地点
1
主要终点
Wound-related complications

研究概览

简要总结

Negative pressure wound therapy (NPWT) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. A prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. The number of wound complications within 21 days will be recorded. As well, the aesthetic appearance and quality of scarring of the scar will be assessed.

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
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong.

排除标准

  • Patients using steroid, or other immune modulators that is known to affect wound healing, prior surgery to the knee or hip, skin condition such as eczema that would result in poor healing or widen scars, patients with a known significant history of hypertrophic scarring or keloid.

结局指标

主要结局

Wound-related complications

时间窗: 21 days after surgery

Recurrence of wound exudate, surgical site infections, dressing-related issues, readmission to hospital and any further surgical interventions will be documented by the research personnel status at 21 days after the index operation.

次要结局

  • Multi-category visual analogue scale(21 days after surgery)
  • Patient Scale and Observer Scale (POSAS)(21 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Tim-Yun Michael ONG

Clinical Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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