Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05462860

Suprathel® 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

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.

CONDITIONS

Official 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 6518 years and 6575 years
  • Acute partial thickness burns by friction, contact, scalding from hot liquids and flame
  • Total body surface area (TBSA) burn 652%; treatment area excludes face, neck, scalp, and feet
  • Third-degree burns TBSA 654% (not included in treatment area)
  • Able and willing to sign informed consent or via legally authorized representative
Not Eligible

You will not qualify if you...

  • Burn wounds due to electrical, radioactive, or frostbite injury
  • Infection in the wound area at admission, as determined by physician
  • Pregnancy or lactation
  • Unable to follow protocol or likely to be non-compliant
  • Participation in another burn wound interventional study within 90 days or during this study
  • Prisoners
  • Life expectancy less than 6 months
  • Receiving steroids, chronic anticoagulants, or immune suppressive treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

K

Kristin Anselmo

CONTACT

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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