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临床试验/NCT03701152
NCT03701152Unknown不适用

Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers

Badr University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Wound size

研究概览

简要总结

Negative Pressure Wound Therapy (NPWT), is a non invasive wound management tool which develops from negative pressure being applied to the wound. This promotes healing through the removal of infectious materials and enhancing granulation tissue formation. NPWT eases debridement as well as promoting healing of different types of wounds.

详细描述

Assessment of wound surface area was done by a graded plastic sheet and a metric graph paper, by counting the complete squares of the metric graph paper, while the wound size was done by using a 10 cm syringe filled with dermazin cream and filling the wound with it.

Negative pressure device: VAC system 125mmhg (KCI negative pressure equipment).

Wound surface area tracing tools:

  • Sterilized transparent film.
  • Fine tipped transparent marker.
  • Carbon and a white A4 papers.
  • Metric graph paper (1mm²).

Wound volume assessment procedure:

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
Single (Participant)

入排标准

年龄范围
27 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • They were free from immune deficiency diseases or collagen diseases.
  • All patients were homeostasis.
  • All patients were medically stable.
  • All cases were chronic and did not heal with other treatment methods

排除标准

  • Malignancies or receiving radiotherapy.
  • Dermatological diseases.
  • Deep venous thrombosis.
  • Renal failure.
  • Immunosuppressant or anticonvulsants therapies.

研究组 & 干预措施

Negative pressure therapy

Experimental

Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Continuous course

干预措施: Negative pressure therapy (Device)

Investigator

Experimental

Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Splitted course

干预措施: Negative pressure therapy (Device)

结局指标

主要结局

Wound size

时间窗: 8 weeks

Wound surface area

时间窗: 8 weeks

次要结局

未报告次要终点

研究者

发起方
Badr University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashraf Hassan

Professor

Badr University

研究点 (2)

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