Modified Cotton Dressing for Treating Chronic Wounds

描述(由申请人提供)： 这项建议的目标是开发一种廉价但复杂和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。基质金属蛋白破坏伤口内的基质。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，以及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。其他的还在开发中。在完成了第一阶段的任务后，第二阶段将包括以下具体目标：(1)DAG敷料制备：根据FDA GLP/GMP设备指南，用于我们美国农业部设施的人体压疮。(2)临床疗效：该敷料将在适当的排除和纳入标准下用于30例压疮患者(每敷料组10分)。在使用敷料之前和研究结束时，将测量伤口液和伤口活检组织中的蛋白酶活性(基质金属蛋白酶-8和弹性蛋白酶)。敷料将每天更换，并将敷料保存起来，以便进行蛋白酶定量。每周用凝胶模型测定创口体积。每个患者将作为他或她自己的对照，使用湿的生理盐水纱布治疗期间，将有一个纱布对照。(3)临床市场敷料的生产将在我们的美国农业部设施中为临床研究生产。如果在里士满、新奥尔良和德罗亚尔的TT团队成员已经并将继续开会解决在开发阶段发生的任何问题。DeRoyal在将伤口敷料设备推向市场方面与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.