Recruiting

KeraStat® Gel with Morphine

Sponsor:

The Metis Foundation

Code:

NCT05217160

Conditions

Wound of Skin

Burns

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KeraStat® Gel with Morphine application

KeraStat® Gel application

Study Details

Brief 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.

Conditions

Wound of Skin

Burns

Study ID

NCT05217160

Start date

May 11, 2021

Status verified date

Jan, 2022

Completion date

May 31, 2022

Anticipated

Primary completion date

May 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 complete the VAS pain score in pain journal
5. Pregnant or nursing
6. Prisoner
7. Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KeraStat® Gel with Morphine

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.

Instructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above.

active comparator: KeraStat® Gel

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 5mL tubes.

Instructions for application as above will be taught to subjects and instructions will be provided as subjects themselves or designated caretakers or home-care personnel will change their dressings as instructed by their physician with the addition of KeraStat® Gel administration as outlined above.

Interventions

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.

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.

Primary outcome measure

  • Change in Visual Analog Scale [ Time Frame: Day 0 and Every 2 weeks for up to 12 weeks ]
  • Change in Adverse event assessment [ Time Frame: Day 0 and Every 2 weeks for up to 12 weeks ]

Central Contacts and Locations

Central contacts

Victoria Diaz, RN

210-916-5760Diaz@metisfoundationusa.org

Locations

South Texas Aesthetic and Reconstructive Surgery

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Victoria Diaz

210-569-1140diaz@metisfoundationusa.org

More Information

Sponsor

The Metis Foundation

Last update posted

Feb 1, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Metis Foundation on 2022-02-01.