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

Plain Language Summary

Simplified for easier understanding

This pilot study tests a special gel (KeraStat Gel) that delivers morphine directly into a wound to help manage pain from non-healing, painful sores and ulcers without the side effects of taking oral morphine. Applying pain medication directly to the wound may provide relief right where it's needed. You may be eligible if: - You are 18 years or older - You have an open wound or ulcer between 1 and 300 cm² in size - Your wound is mostly free of dead or infected tissue - Your pain score is at least 2 out of 10 on the pain scale - Any tunneling in the wound is less than 3 cm from the wound edge You may NOT be eligible if: - You have a known allergy to any ingredient in KeraStat Gel or to morphine - Your wound has heavy drainage or a lot of dead tissue - Your wound shows signs of active infection - You cannot complete a pain journal - You are pregnant or nursing - You are a prisoner Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

South Texas Aesthetic and Reconstructive Surgery

San Antonio, Texas, United States

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NCT05217160

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