Clinical trial NCT05462860: Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
Official title: Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound of Skin
Burns
Lead sponsor: The Metis Foundation
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Proof of concept
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for autograft application
timeFrame: 21 days
Secondary outcomes:
measure: Wound infection rate, wound closure of the region
timeFrame: 2 weeks, 3 weeks, and 6 weeks after application (without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart)
measure: Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS).
timeFrame: Mid (3-9 months) and long term (52 weeks)
measure: Patient-reported perception of pain based on the Visual Analog Scale
timeFrame: After initial application (Day 0) and weekly
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Jaycee Burn Center
state: North Carolina
Study officials:
affiliation: Metis Foundation
name: Rodney Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: