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临床试验/NCT03135964
NCT03135964已完成不适用

The Study of Wound Dressings for Portable Negative Pressure Wound Therapy

Tainan Municipal Hospital2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2011年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
2
主要终点
The reduction rate of pressure ulcer size

研究概览

简要总结

Introduction Negative pressure wound therapy (NPWT), also known as topical negative pressure, has become a popular therapy for the treatment of many acute and chronic wounds. In many randomized controlled trials(RCTs), NPWT also has benefit in diabetic foot ulcer and pressure ulcer. However, most studies used commercial VAC device in combined with polyurethane (PU) foam. It is not yet clear where NPWT combined with gauze as wound filler is as effective as the PU foam. This RCT evaluated the efficacy of the gauze and PU foam, two kinds of fillers routinely used in negative pressure wound therapy, on the healing of the diabetic lower-extremity ulcers and the pressure ulcer.

Methods From 2010/1 to 2015/01, the in-patient persons with difficult to heal diabetic ulcer or Grade 4 pressure ulcer were enrolled. These patients were divided into two groups randomly. The letter of consent was signed by the patient or patient's family. After debridement of the infective wound, the wound of experimental group was packed with a moistened Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien). A noncollapsible drainage tube (Blake drain, Ethicon) was applied to the wound, and then sealed with 3M Tegaderm Film. The system was connected to a 1-bottle water-seal chest drainage system and to standard wall suction at 125 mmHg negative pressure. The dressing was changed at 72- to 96-hour intervals (twice a week) for a period of 3 weeks. To the control group, the PU foam dressing from KCI was packed and sealed to the wound with the same continuous wall suction at -125mmHg. Investigators observed and recorded the ulcer area twice a week on each time of changing dressing in the following 3 weeks. The percentage of wound area reduction(PWAR) was used as a predictor of wound healing. The repeated measuring data were analyzed using linear mixed mode with SPSS statistical software. This clinical study was approved and monitored by Institutional Review Board of Show Chwan Memorial Hospital.

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

性别
All
接受健康志愿者

入选标准

  • in-patient persons with the pressure ulcer or diabetic ulcer

排除标准

  • Patient who has uncontrolled medical condition, such as sepsis, cellulitis
  • Patient with diabetic ulcer who has severe PAOD untreated

结局指标

主要结局

The reduction rate of pressure ulcer size

时间窗: up to 3weeks

次要结局

  • The reduction rate of diabetic foot ulcer size(up to 3weeks)

研究者

发起方
Tainan Municipal Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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