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

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.

Conditions

Wound of Skin, Burns

Study Overview

Study Details

Study overview

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.

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

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

Condition
Wound of Skin
Intervention / Treatment

-

Contacts and Locations

San Antonio

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Metis Foundation,

Study Record Dates

2022-05-31