跳至主要内容
临床试验/NCT01067729
NCT01067729终止不适用

A Multi-Center, Randomized, Prospective Study of the Treatment of Superficial Partial-Thickness Burns: AWBAT™ vs. Biobrane®

Aubrey Inc.6 个研究点 分布在 1 个国家开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
试验地点
6
主要终点
Rate of healing

研究概览

简要总结

The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.

详细描述

The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Superficial partial thickness burns
  • Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
  • One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
  • Burn wounds measuring >2% - <40% TBSA
  • Patient age: >1 - 70 years

排除标准

  • Ventilator dependence
  • Pregnancy/Lactation
  • Mechanism of injury was electrical, chemical or frostbite
  • Co-morbidity which may compromise healing
  • Known allergy to porcine or porcine products

结局指标

主要结局

Rate of healing

时间窗: Day 14

次要结局

  • Scarring(6 months, 1 year, 18 months and 2 years)

研究者

发起方
Aubrey Inc.
申办方类型
Industry

研究点 (6)

Loading locations...

相似试验

A Postmarket Randomized Study of the Treatment of... | 临床试验