Wound Healing Efficacy of Topical Papaverine Dressing in Ischemic Diabetic Foot Wound - A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Healthy granulation of wound
研究概览
简要总结
This study is randomized double blind, interventional pilot study with sample size 30 patients having 15 patients in each group.
Topical O2 therapy is added from 1st post-operative day. The size of the wound would be assessed on first day and daily. On first post-operative dressing i.e., after 24 hours of surgery the dressing protocol will be initiated.
For dressing, the clinical investigator will be given coded drug filled syringe as per the sequential allocation of coded syringe to add on standard dressing protocol. Syringe will be filled either with papaverine or normal saline as per randomization sequence. Patient has been given normal saline or papaverine will not be known to any person who is doing dressing or collecting the wound assessment data.
Dressing protocol:
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The wound will be clean with normal saline and mopped with sterile gauze.
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Either interventional drug i.e. Papaverine injection in concentration of 30mg/ml or Normal saline as placebo will be applied as 1ml per 2-2.5 sq. cm of wound area.
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It will be applied as topical spray on the wound with the help of 24 G blunt needle and syringe.
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Wound will be covered with sterile gauze and standard dressing covering.
Next dressing will be done after 24 hours and daily up to 30 days or till healthy granulation occurs with documentation of wound healing parameters in terms of –
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Size of wound
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Quality of granulation – pale or pink or red
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Exudates – yes or no, If yes - serous or pus
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Surrounding skin – edema present or not
Wound will be observed for healthy granulation for 30 days. A day when healthy granulation occurs will be noted. During 30 days if healthy granulation occurs wound is prepared for skin grafting or healed by secondary intention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •DF wound having ischemia on clinical and diagnostic assessment having any of the following:
- •Pale granulation.
- •Moderate to severe obstruction in blood flow supplying the wound on Color Doppler OR Angiography OR clinical examination OR ABI (any one of them) 3.Despite of having critical limb ischemia patient has not undergone vascular intervention for various reasons by informed choice.
排除标准
- •Patient not willing for consent.
- •Patient underwent Angioplasty.
- •Patient having good blood supply to wound.
结局指标
主要结局
Healthy granulation of wound
时间窗: 30 days
次要结局
- Skin grafting(30 days)
- Healed by secondary intention(30 days)
研究者
Dr Amit Burande
Mahalaxmi health care PVT LTD