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Opioid Analgesic

KeraStat® Gel with Morphine for Skin Wound

Phase 4
Waitlist Available
Research Sponsored by The Metis Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 and every 2 weeks for up to 12 weeks
Awards & highlights

Study 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.

Eligible Conditions
  • Skin Wound
  • Burns

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 and every 2 weeks for up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 and every 2 weeks for up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Adverse event assessment
Change in Visual Analog Scale
Secondary outcome measures
Change in Pressure Sore Quality of Life questionnaire

Side effects data

From 2015 Phase 4 trial • 84 Patients • NCT02009722
52%
Moderate to Severe Pruritus
40%
Moderate to Severe Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intrathecal Morphine
Intrathecal Hydromorphone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: KeraStat® Gel with MorphineExperimental Treatment1 Intervention
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.
Group II: KeraStat® GelActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

The Metis FoundationLead Sponsor
8 Previous Clinical Trials
232 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers
2021. "Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05217160.
~6 spots leftby Apr 2025
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