Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05462860

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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

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