RecruitingPhase 4NCT05217160

Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers

Sponsor

The Metis Foundation

Enrollment

24 participants

Start Date

May 11, 2021

Study Type

INTERVENTIONAL

Conditions

Burns Wound of Skin

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Subjects age 18 or older able to provide informed consent.
Ulcer size 1-300 cm2
\. 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 Criteria8

Subjects who meet any of the following criteria will be excluded from the study:
Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine
Wound has heavy or high-volume exudate or necrotic tissue
Clinical signs of infection or contamination of the wound
Subjects unable to complete the VAS pain score in pain journal
Pregnant or nursing
Prisoner
Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study

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Interventions

DRUGKeraStat® Gel with Morphine application

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.

DRUGKeraStat® Gel application

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.