Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds

Last updated: April 8, 2025
Sponsor: The Metis Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Skin Wounds

Treatment

Suprathel®

Clinical Study ID

NCT05462860
Suprathel
CDMRP-MB200024
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or Female ≥18 years and ≤75 years

  • Acute partial thickness burns by friction, contact, scalding from hot liquids andflame

  • TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thicknessburns excluding face, neck, scalp, and feet

  • TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)

  • Subject is able and willing to sign Informed Consent or via legally authorizedrepresentative

Exclusion

Exclusion Criteria:

  • Study Wound due to electrical, radioactive, or frostbite-related injury

  • Infection of wounds in the study area at admission per Investigator or treatingphysician discretion

  • Pregnancy/lactation

  • Subjects who are unable to follow the protocol or who are likely to be non-compliant

  • Participation in an active treatment arm of a burn wound related interventionalstudy within 90 days of Screening Visit or during the study

  • Prisoners

  • Life expectancy less than 6 months

  • Subjects who are receiving steroids, chronic anticoagulants, or immune suppressivetreatment

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: Suprathel®
Phase:
Study Start date:
September 18, 2024
Estimated Completion Date:
June 29, 2026

Study Description

We are advocating the study of Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany), a synthetic wound dressing made of polymers of D-,L- lactate, and ε caprolactone, in the early coverage of burns for use in Large Scale Combat Operations (LSCOs) as compared to standard of care. The rationale for studying Suprathel® is its favorable physical characteristics as a portable treatment, ease of application by personnel without formal medical training, proven efficacy in improving outcomes after partial-thickness burn injury to include better pain control, preliminary evidence in decreasing burn wound conversion, and the lack of adverse consequences in covering indeterminant depth or full thickness burns.

Connect with a study center

  • North Carolina Jaycee Burn Center

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.