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

PHASE4RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 11, 2021

Primary Completion Date

May 31, 2022

Study Completion Date

May 31, 2022

Conditions
Wound of SkinBurns
Interventions
DRUG

KeraStat® 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."

DRUG

KeraStat® 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."

Trial Locations (1)

78229

RECRUITING

South Texas Aesthetic and Reconstructive Surgery, San Antonio

All Listed Sponsors
lead

The Metis Foundation

OTHER