RECRUITING

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

Description

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

Wound of SkinBurns
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Related Conditions:

Wound of SkinBurns

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Wound of Skin
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

North Carolina Jaycee Burn Center, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Metis Foundation,

Rodney Chan, MD, PRINCIPAL_INVESTIGATOR, Metis Foundation

Study Record Dates

2025-09-29