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临床试验/CTRI/2025/08/092962
CTRI/2025/08/092962招募中2/3 期

Development and Efficacy Testing of Variable Pressure Flat Ultrathin Water Jet Device for Debridement and Dissection

Indian Council of Medical Reasearch1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Wound healing time, wound healing rate. Reduction in wound SINBAD score.

研究概览

简要总结

Debridement and dissection are most important aspects of surgery. Most of the chronic non-healing ulcers are covered with necrotic materials and bio-films making them complicated to manage. Current practice is surgically removing the necrotic materials from the wounds using scalpel blades and scissors. The major complications of this procedure are significant amount of blood loss, time consuming, loss of healthy granulation tissues and remaining of residual sloughs in between clefts of the wounds. These lead to repetition of the procedure and delayed wound healing. To overcome these challenges we propose a variable pressure flat ultrathin water jet which will effectively remove the necrotic and dead tissues while preserve the healthy tissue and minimize the amount of blood loss during debridement. Variable pressure flat ultrathin water jet had never been tried before for debridement and dissection. Water jet can be effectively applied to the clefts of the wounds leading to complete removal of slough. Mostly the procedure can be completed very quickly with no requirement of anesthesia at all. Again the water jet debridement procedure can be repeated daily with minimum morbidity till healthy granulation tissue appears. Variable pressure flat ultrathin water jet can be effectively used for dissection. Optimum water jet pressure with precise dimension can effectively divide the intervening fat and loose areolar tissue leading to separation and visualization of vital structures during difficult surgeries such as axillary dissection and pancreatic necrosectomy. This method will avoid the potentially dangerous complications of sharp dissection using scissors or diathermy. The variable pressure flat ultrathin water jet will reduce the dissection time and aid in proper identification of different structures with minimum complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • patients above 18 years of age, suffering from different types chronic (viz.
  • diabetic foot ulcer), traumatic , and burn ulcers.

排除标准

  • Moribund patients and ulcers complicated by lymphedema were excluded from the study.

结局指标

主要结局

Wound healing time, wound healing rate. Reduction in wound SINBAD score.

时间窗: Baseline SINBAD score at the recruitment. Per week wound SINBAD score will be noted. Final score will be noted on wound closure.

次要结局

  • Quality of life(6 months, 1 Year.)

研究者

发起方
Indian Council of Medical Reasearch
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Subhasish Sarkar

College of Medicine and Sagore Dutta Hospital

研究点 (1)

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