A Randomised Clinical Trial of the Negative Pressure Wound Therapy Versus Conventional Dressing for Pressure Ulcers Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- ulcer size
研究概览
简要总结
This study will compare the NPWT using the NPD to the conventional wound dressing and specifically evaluating (i) reduction of wound surface area and depth, (ii) removal of slough and formation of granulation tissue
详细描述
Initial debridement of slough and necrotic tissue was performed in all patients at the time of admission and before their being allocated in a group.
it's 3 groups:
Group (A): conventional dressing :
acting by:preventing pus, the findings from the review indicate that decreasing frictional forces transmitted to the patient's skin is achieved by use of a dressing with an outer surface made from a low friction material.
The surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound. Dressing changes will be performed once or twice daily depending on the soakage of the dressing.
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
盲法说明
Based on determining the main outcome variable, the estimated minimum required sample size is 39 patients (13 patient in each group
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stages three and four PU as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
排除标准
- •wound with necrotic tissue unlikely to tolerate debridement. Exposed Vessels, Nerves and or organs. Active bleeding. Ischemic limb. Opening into body cavity
研究组 & 干预措施
conventional dressing
The surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound. Dressing changes will be performed once or twice daily depending on the soakage of the dressing
干预措施: negative wound pressure therapy (Device)
negative pressure wound therapy
We will place a nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape. The dressing will be connected to the machine through tubing that was connected to the canister. Continuous pressure of 200 mm Hg will be applied. The dressing will be changed three times a week.
干预措施: negative wound pressure therapy (Device)
结局指标
主要结局
ulcer size
时间窗: 3 weeks
measured for its greatest length ,depth and width with flexigrid Opsite.
次要结局
未报告次要终点
研究者
issraa Aly
resident doctor
Assiut University