Modified Cotton Dressing for Treating Chronic Wounds

点击翻译按钮获取中文摘要

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.