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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wound of Skin, Burns

Intervention / Treatment
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* Other: Suprathel®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Proof of concept
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprathel® dressing<br>The Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use | Other: Suprathel®<br>* Application of standard of care dressing.®<br>* Other names: standard of care;|
| Active Comparator: Standard of Care<br>The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement. | Other: Suprathel®<br>* Application of standard of care dressing.®<br>* Other names: standard of care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for autograft application | The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application. | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound infection rate, wound closure of the region | Incidence of infections and inflammatory response and scar development | 2 weeks, 3 weeks, and 6 weeks after application (without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart) | 
| Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS). | Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring. | Mid (3-9 months) and long term (52 weeks) | 
| Patient-reported perception of pain based on the Visual Analog Scale | 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. | After initial application (Day 0) and weekly |