The Metis Foundation
This study is intended to provide information from subjects who currently have painful, chronically open wounds and assess the pain reduction capacity of KeraStat® Gel with Morphine. In gathering data from subjects who have baseline pain from their chronically open wounds, the investigators can then evaluate the capacity of KeraStat® Gel plus Morphine in reducing the subjects daily pain levels, pain associated with dressing changes, and pain medication consumption.
Chronic wounds pose a serious challenge to wound care professionals, as open and non-healing ulcers are often painful and difficult to treat. Patients are less compliant because of their pain and also run the risk of increased pain medication exposure in treating these wounds. A great deal of healthcare resources are dedicated to the treatment of non-healing open wounds. KeraStat® Gel offers a novel method for the topical delivery of Morphine to manage pain during the treatment of healing these problematic wounds. Proof of concept work showed that a single treatment application of opioid-load…
Inclusion Criteria: 1. Subjects age 18 or older able to provide informed consent. 2. Ulcer size 1-300 cm2 4\. Undermining/tunneling \<3 cm from wound margin 5. Grossly free of necrotic and/or infected tissue 6. Baseline minimum of 2 on VAS pain scale Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine 2. Wound has heavy or high-volume exudate or necrotic tissue 3. Clinical signs of infection or contamination of the wound 4. Subjects unable to…
Administration and application of KeraStat® Gel with Morphine (Bi-Weekly): KeraStat® Gel with Morphine will be formulated by mixing liquid Morphine 25mg/mL into 5mg of KeraStat, this will be individually packaged in 5mL tubes at a concentration of 5mg/mL. Each 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject. Home Administration and application of KeraStat® Gel with Morphine (Every 1-3days): Dressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel with Morphine in 5mL tubes.
Administration and application of KeraStat® Gel (Bi-Weekly): Each 5mL tube will cover and area of 300cm2 which is approximately 1.5% TBSA of an average, 60kg subject. Home Administration and application of KeraStat® Gel (Every 1-3days): Dressing is to be changed every 1-3 days, no more than once a day. Subjects will be provided the appropriate amount of pre-compounded KeraStat® Gel in 5mL tubes.
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