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Recruiting

NCT Number: NCT05462860

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Booker King, MD

PRINCIPAL_INVESTIGATOR

Carter

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female ≥18 years and ≤75 years
  • Acute partial thickness burns by friction, contact, scalding from hot liquids and flame
  • TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns 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 authorized representative

Exclusion criteria

  • Study Wound due to electrical, radioactive, or frostbite-related injury
  • Infection of wounds in the study area at admission per Investigator or treating physician 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 interventional study 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 suppressive treatment

Treatment and study plan

Suprathel®

Other

Application of standard of care dressing.®

Other names: standard of care

Primary outcomes

  1. Need for autograft application

    Time frame: 21 days

    The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application.

Secondary outcomes

  1. Wound infection rate, wound closure of the region

    Time frame: 2 weeks, 3 weeks, and 6 weeks after application (without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart)

    Incidence of infections and inflammatory response and scar development

  2. Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS).

    Time frame: Mid (3-9 months) and long term (52 weeks)

    Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring.

  3. Patient-reported perception of pain based on the Visual Analog Scale

    Time frame: After initial application (Day 0) and weekly

    Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) prior to and after application of the first dressing and subsequent dressings.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Anselmo

CONTACT

[email protected]

Victoria Diaz, RN

CONTACT

[email protected]

2105691140

Sponsors and collaborators

Lead sponsor

The Metis Foundation

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 18, 2022
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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