跳至主要内容
临床试验/NCT05883033
NCT05883033尚未招募不适用

Comparative Study Between Vacuum Assisted Closure (VAC) and Conventional Dressing in the Healing Process of Necrotizing Fasciitis After Surgical Debridement.. Clinical and Laboratory Study.

Assiut University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6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
30
试验地点
1
主要终点
Hospital staying length

研究概览

简要总结

Find out the best management of Necrotizing Fasciitis after surgical debridement

详细描述

Necrotizing fasciitis is a life-threatening condition that can occur as a result of trauma or foreign bodies in surgical wounds as well as idiopathically. Necrotizing fasciitis is characterized by a progressive infection in fascial planes with necrosis of the subcutaneous tissue. Necrotizing fasciitis affects the extremities more frequently than central areas. Risk factors for necrotizing fasciitis include diabetes mellitus, trauma wound infections, decubitus ulcers, alcoholism, carcinoma, peripheral vascular disease, smoking, and intravenous drug abuse. A varieties of micro-organisms, including gram-positive group A streptococcus, haemolytic streptococci, and staphylococcus aureus; gram-negative Enterobacteriaceae, Escherichia coli, Klebsiella spp., and Proteus spp.; anaerobes including Peptostreptococcus, Clostridium, and Pacteroides; and fungi such as Candida and acid-fast bacteria have all been implicated in the pathogenesis of Necrotizing fasciitis.

Necrotizing fasciitis is a surgical emergency for detoxification by debridement with good antibiotic coverage. It has mortality rate reaching 20-30% , this mortality rate is high and requires prompt diagnosis, antibiotic treatment and extensive necrosectomy up to intensive care units admission in some cases, the aim of our prospective analysis is to assess with a hypothesis-generating and exploratory purpose the possible role of VAC versus ordinary dressings in the wound therapy of Necrotizing Fasciitis in terms of expected time for wound closure and survival rate.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Immunocompromised patients such as; diabetic, HIV and leukaemia.
  • And other chronic debilitating diseases.

排除标准

  • Necrotizing Fasciitis of Head and neck and upper limbs.

结局指标

主要结局

Hospital staying length

时间窗: Baseline

the difference in hospital stay length between patients with necrotizing fasciitis who received conventional management versus those treated with vacuum-assisted closure. A systematic review showed a significant difference between the two methods

次要结局

  • Expected closure of the wound by secondary intention(Baseline)
  • Required other stages of debridement(Baseline)

研究者

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

Mario Youhana Saba

Resident Dr

Assiut University

研究点 (1)

Loading locations...

相似试验

VAC and Conventional Dressing in the Healing Process... | 临床试验