跳至主要内容
临床试验/NCT05653297
NCT05653297尚未招募不适用

A Randomized Study of The Use of Negative Pressure Wound Therapy in Traumatic Skin & Soft Tissue Loss

Assiut University0 个研究点目标入组 50 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Granulation tissue formation

研究概览

简要总结

Assessment of the effectiveness of negative pressure wound therapy on post-traumatic wounds, as regard to :

  • The period of granulation tissue formation.
  • The infection rate in NPWT in comparison to conventional dressing.
  • The rate of graft take after NPWT.
  • The length of hospital stay.

详细描述

Over the last 15 years, negative-pressure wound therapy "NPWT" has become commonly used for treatment of a wide variety of complex wounds. Many clinicians have noted a dramatic response when negative-pressure wound therapy technology has been used, prompting a number of scientific investigations related to its mechanism of action and clinical trials determining its efficacy.

NPWT is a modality that has shown great promise and delivered significantly better results in the clinical care of acute as well as chronic wounds. It is designed to seal the wound site using foam dressing linked to an electronic pump, which applies a pressure ranging from -75 to -150 mmHg. As a matter of fact, NPWT's impact on wound healing appears to be the consequence of multiple effects, each contributing to the overall positive influence on wound healing. Current research indicates that there are four primary NPWT mechanisms of action: Macrodeformation, Microdeformation, Fluid removal and Environmental control of the wound.

Even if the role of NPWT in promoting wound healing has been largely accepted, there is a lack of evidence (few high-level clinical studies) regarding its effectiveness and further research is needed to better understand the mechanisms of action.

Traumatic wounds vary from abrasions and minor skin incisions or tears to wounds with extensive tissue damage or loss and damage to bone and internal organs. Delayed wound healing particularly in difficult wounds is a major concern, It leads to pain, morbidity, prolonged treatment, and require major reconstructive surgery which imposes enormous social and financial burden.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • No age preference.
  • No gender preference.
  • Acute traumatic wounds.
  • Admitted to the hospital.

排除标准

  • Exposed Vessels, Nerves & Organs.
  • Active bleeding.
  • Ischemic limb.
  • Opening into body cavity.
  • Vulnerable body organs.
  • Necrotic tissue with eschar present.

结局指标

主要结局

Granulation tissue formation

时间窗: 2 weeks

Healthy granulation tissue appears pink to red due to new capillary formation, soft to touch, moist appears "bumpy," and typically painless.

Graft Take

时间窗: 4 days after coverage

The graft take assessment by clinical examination

次要结局

  • Length of hospital stay(1 month)

研究者

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

David Philip Ryad Gadelsayed

Principal Investigator

Assiut University

相似试验

Negative Pressure Wound Therapy in Traumatic Skin... | 临床试验