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临床试验/NCT03675568
NCT03675568撤回不适用

Non-cultured Autologous Keratinocyte Suspension for Treatment of Deep Dermal Burn and Post-Burn Raw Area Versus Traditional Split Skin Graft

Assiut University0 个研究点开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
mean Hospital stay

研究概览

简要总结

A study comparing effect of non-cultured autologous keratinocyte suspension on burn wounds treatment compared with traditional split skin graft

详细描述

Burn injuries are complicated wounds to manage with a relative high mortality rate in especially large area burns and elderly patients.

Substantial tissue damage and extensive fluid loss can cause impaired vital functions of the skin. When healing is delayed, the potential short term common complications include wound infection affecting the local healing process or systemic inflammatory and immunological responses which subsequently can cause life threatening sepsis and multi-organ failure.

Fortunately, survival rates have improved drastically over the last century due to advancements in burn care such as early surgical intervention, critical care support and wound care.

For many years the "gold standard" for treating wounds of burn patients has been transplantation with an autologous split skin graft. In patients with extensive burn wounds donor sites may be limited. In order to cover all the wounds, the patients often need multiple operations and/or the skin had to be expanded as much as possible.

However, the current different expansion techniques and treatments [mesh and Meek-Wall] frequently lead to scar formation, especially in the large mesh inter-sites.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Deep dermal burns more than 10% total body surface area which require surgical debridement and epidermal replacement.
  • Post-burn raw area more than 10% total body surface area

排除标准

  • Presence of pre-existing local and systemic bacterial infections.
  • Pre-existing medical conditions that would interfere with wound healing (uncontrolled diabetes mellitus, malignancy, congestive heart failure, autoimmune disease, renal failure, corticosteroids and immunosuppressive drugs).

结局指标

主要结局

mean Hospital stay

时间窗: 1 month

Number of days patient stays admitted

次要结局

  • mean healing time(1 month)

研究者

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

Sara Diefy Salem

Principal investigator

Assiut University

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