Burns, Wound of Skin
Conditions
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.
Interventions
OTHERSuprathel®
Application of standard of care dressing.®
Sponsors
The Metis Foundation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Proof of concept
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for autograft application | 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
| Measure | Time frame | Description |
|---|---|---|
| Wound infection rate, wound closure of the region | 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 |
| Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS). | Mid (3-9 months) and long term (52 weeks) | Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring. |
| Patient-reported perception of pain based on the Visual Analog Scale | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRodney Chan, MD
Metis Foundation
Outcome results
None listed