Modified Cotton Dressing for Treating Chronic Wounds

描述（由申请人提供）： 该提案的目的是开发一种廉价但复杂且有效的慢性伤口治疗敷料。弹性蛋白酶破坏伤口中的生长因子及其受体。MMPs破坏伤口内的基质。因此，通过减少伤口中的这些因素，将减少对细胞因子及其受体的破坏，并减少胶原基质的分解。这是我们计划用于临床的第一种敷料。其他人正在开发中。完成第一阶段的任务后，第二阶段将包括以下特定目标：（1）DAG敷料制备：根据FDA GLP/GMP器械指南，在我们的USDA工厂用于人类压疮。(2)临床耐受性：根据适当的排除和入选标准，该敷料将用于30名患者（每个敷料组10名患者）的压疮。在敷料贴敷前和研究结束时，将测量伤口液和伤口活检组织中的蛋白酶活性（MMP-8和弹性蛋白酶）。每天更换敷料，保存敷料用于蛋白酶定量。每周使用凝胶模型测定伤口体积。每例患者将使用湿盐水纱布治疗期作为其自身对照，并将有纱布对照。(3)临床市场产品敷料的生产将在我们的USDA工厂生产临床研究敷料。成员，如果TT团队在里士满和新奥尔良和德罗亚尔已经，并将继续开会，以解决任何问题，发生在发展阶段。DeRoyal在将伤口敷料器械推向市场方面与FDA有着丰富的经验，并将非常积极地帮助这些行动。

DESCRIPTION (provided by applicant): The objective of this proposal is to develop an inexpensive but sophisticated and effective dressing for chronic wound treatment. Elastase destroys growth factors in the wound as well as their receptors. MMPs destroy matrix within the wound. Therefore, by reducing these factors in the wound, there will be reduced destruction of cytokines and their receptors as well as a reduction in collagen matrix breakdown This is our first dressing planned for clinical use. Others are in development. Having competed the tasks of Phase I, Phase II will include the following SPECIFIC AIMS : (1) DAG DRESSING PREPARATION: for use in human pressure ulcers under FDA GLP/GMP device guidelines at our USDA facility. (2) CLINICAL EFFECTIVENESS: this dressing will be used in the pressure ulcers of 30 patients (10 pts per dressing group) under appropriate exclusion and inclusion criteria. Protease activity (MMP-8 and elastase) will be measured in wound fluid and wound biopsies before dressings are applied and at the termination of the study. Dressings will be changed daily and dressings saved for protease quantitation. Wound volume will be determined with geltrate molds each week. Each patient will serve as his or her own control using a moist saline gauze treatment period and there will be a gauze control. (3) PRODUCTION OF DRESSING FOR PRODUCT FOR CLINICAL MARKET Dressings will be produced for the clinical studies at our USDA facilities. Members if the TT team in Richmond and New Orleans and DeRoyal have, and will continue to meet to solve any problems that occur during the development phase. DeRoyal has extensive experience with the FDA in bringing wound dressing devices to the market and will be very active in helping with these actions.