RecruitingNot ApplicableNCT05462860

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

Sponsor

The Metis Foundation

Enrollment

21 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

Burns Wound of Skin

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria8

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

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