RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-11
Study Completion:2022-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05217160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects age 18 or older able to provide informed consent.
  2. 2. Ulcer size 1-300 cm2
  3. 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
  1. 1. Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine
  2. 2. Wound has heavy or high-volume exudate or necrotic tissue
  3. 3. Clinical signs of infection or contamination of the wound
  4. 4. Subjects unable to complete the VAS pain score in pain journal
  5. 5. Pregnant or nursing
  6. 6. Prisoner
  7. 7. Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study

Contacts and Locations

Study Contact

Victoria Diaz, RN
CONTACT
210-916-5760
Diaz@metisfoundationusa.org

Study Locations (Sites)

South Texas Aesthetic and Reconstructive Surgery
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: The Metis Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-11
Study Completion Date2022-05-31

Study Record Updates

Study Start Date2021-05-11
Study Completion Date2022-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Wound of Skin
  • Burns