Actively Recruiting
Suprathel4 Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
Led by The Metis Foundation · Updated on 2025-04-10
21
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the use of Suprathel4, a synthetic wound dressing made from polymers of D-,L-lactate and b5 caprolactone, to help heal burn wounds during prolonged field care situations, especially in large-scale combat operations. The study compares Suprathel4 to standard wound care to see if it can reduce the need for skin grafting, pain, infections, medical staff workload, scarring, and treatment costs. Suprathel4's portability and ease of use by non-medical personnel make it a promising option for early burn coverage. Participants will be randomly assigned to one of two groups: one receiving the Suprathel4 dressing after standard cleaning and debridement of the wound, and the other receiving standard wound care dressings following the same cleaning process. The Suprathel4 dressing will be maintained according to the manufacturer's instructions. The study focuses on partial-thickness burns covering at least 2% of the body surface area but excludes certain body areas like the face and feet. During the study, participants will be monitored for the need for skin grafting over 21 days. Other assessments include wound infection rates, wound closure at 2, 3, and 6 weeks, scar healing evaluated by a scar assessment scale over 3 to 12 months, and patient-reported pain levels from the day of application through weekly follow-ups. The study will track these outcomes to determine how Suprathel4 compares to standard care in promoting burn wound healing and reducing complications.
CONDITIONS
Brief Title
Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female aged 18 to 75 years
- Acute partial thickness burns caused by friction, contact, scalding from hot liquids, or flame
- Burn covers at least 2% total body surface area excluding face, neck, scalp, and feet
- Third-degree burns cover 5% or less and are not included as treatment areas
- Able and willing to provide informed consent or have a legal representative consent
You will not qualify if you...
- Burns caused by electrical, radioactive, or frostbite injuries
- Infection in the burn area at admission
- Pregnancy or breastfeeding
- Unable to follow the study protocol or likely to be non-compliant
- Participation in another burn wound treatment study within 90 days
- Prisoners
- Life expectancy less than 6 months
- Receiving steroids, chronic anticoagulants, or immune-suppressive treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive either the Suprathel® dressing or standard of care dressing applied to their burn wounds after cleaning and debridement. The dressing is maintained according to instructions to promote healing and reduce the need for grafting.
Weekly visits for up to 6 weeks
Duration - 3 to 12 months
Participants are monitored for mid and long term clinical scar maturation and patient-reported pain perception.
Visits at 3 to 9 months and at 12 months
Trial Site Locations
Total: 1 location
1
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
V
Victoria Diaz, RN
K
Kristin Anselmo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2