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临床试验/NCT05716503
NCT05716503招募中不适用

Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds

Sohag University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月1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
20
试验地点
1
主要终点
Time of complete healing

研究概览

简要总结

The aim of this thesis is to compare the efficacy of Vacuum assisted closure device versus conventional dressing before and after split thickness skin grafting in diabetic foot wounds.

详细描述

Negative pressure wound therapy is a new noninvasive technique for treating open wounds. It works by removing fluid from the wound bed, reducing edema, and encouraging the growth and perfusion of new granulation tissue.

Vacuum-Assisted Closure device (VAC) helps to remove fluid from open wounds through a sealed dressing and tubing which is connected to a collection container. Vacuum-assisted closure (VAC) can provide stable and persistent negative pressure, and there are several modes to choose from.

VAC has played an important role in helping to close wounds, controlling infection, promoting angiogenesis, increasing blood flow, and promoting granulation tissue growth in wounds. It is now widely applied in all kinds of acute, chronic, and special wounds with good therapeutic results. However, there is a need to pay attention to contraindications and complications of VAC when it is used, avoiding secondary damage due to improper treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age group 20-75 years.
  • Patients with diabetic foot wounds who are scheduled for skin grafting.

排除标准

  • Age <20 years or > 75 years.
  • An obvious septicemia.
  • Foot osteomyelitis.
  • Ulcer resulting from venous insufficiency.
  • Features of malignant ulcer.
  • Patients being treated with corticosteroids, immunosuppressive drugs.
  • Any other serious pre-existing cardiovascular, pulmonary or immunological disease.

结局指标

主要结局

Time of complete healing

时间窗: 1 month

Number of days needed for each patient for complete healing after operation

Period of hospitalization.

时间窗: 2 weeks

Number of days of patient hospitalization before and after grafting

Patient satisfaction of aesthetic outcome

时间窗: 5 months

Number of patients satisfied with the aesthetic result of the operation on a scale of 0-10

Functional outcome

时间窗: 5 months

Number of patients with full range of mobility at site of graft Vs number of patients with limited mobility

次要结局

未报告次要终点

研究者

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

Hady Khaled Elhossiny

Resident of plastic and reconstructive surgery, Sohag University hospital

Sohag University

研究点 (1)

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