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临床试验/NCT00847496
NCT00847496撤回2 期

The Treatment of Partial Thickness Burns: Awbat(r) Versus Biobrane(r)

The University of Texas Medical Branch, Galveston2 个研究点 分布在 1 个国家开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
2 期
状态
撤回
试验地点
2
主要终点
Time to complete Healing

研究概览

简要总结

• To determine if AWBAT, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, lower costs, and improved scarring and long term recovery when compared to Biobrane®.

详细描述

Currently there is no "best covering" or a standard "approved care" for treating partial thickness burns. Several options are available; however, they all have shortcomings. The application of topical antimicrobial dressings is time consuming and the regular dressing changes often associated with pain. Homograft or cadaver skin is often unavailable or in great shortage for skin transplants. Biobrane®, a biosynthetic wound dressing constructed of a silicone film with a nylon fabric partially imbedded into the film, has been available and used at our institute for many years as a skin substitute. It has been shown to reduce pain and the number of necessary dressing changes, and significantly reduced healing time (1). Its main side effects, although rare, are the occasional occurrence of infections and allergic reactions to the material.

Recently, a new product, AWBAT, has been developed for the coverage of partial thickness burns. AWBAT is similar to Biobrane® in terms of silicone membrane thickness, the structure of nylon fabric that gives the dermal substitute its strength, and the use of collagen peptides on the inner side of the membrane. These peptides are used for the purpose of reacting with the fibrin in the wound in order to achieve good initial adherence and to accelerate re-epithelialization. The key novelties of AWBAT are the different pore size and modality of collagen peptide attachments. These two key modifications aim at a reduction of the above mentioned adverse reactions.

The purpose of this study is to compare AWBAT to Biobrane® for covering partial thickness-burn injuries. We wish to determine if AWBAT, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, and improved scarring and long term recovery when compared to Biobrane®.

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

年龄范围
3 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Partial thickness burns between 4% and 40% Total Body Surface Area(TBSA)
  • Full thickness burns not to exceed 10% TBSA,
  • Age as specified

排除标准

  • Full thickness burns that require immediate excision and grafting
  • Known allergic reaction against Biobrane
  • Chemical and electrical burns

结局指标

主要结局

Time to complete Healing

时间窗: 5 - 14 days post injury/membrane application

次要结局

  • Occurence of Infection(entire study period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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