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

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.

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

• Other Suprathel®
  Application of standard of care dressing.®

Primary outcome measures

• Need for autograft application [Time frame: 21 days]

Secondary outcome measures (3)

• Wound infection rate, wound closure of the region [Time frame: 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). [Time frame: Mid (3-9 months) and long term (52 weeks)]
• Patient-reported perception of pain based on the Visual Analog Scale [Time frame: After initial application (Day 0) and weekly]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• North Carolina Jaycee Burn Center — Chapel Hill

Identifiers

NCT: NCT05462860 · Suprathel · CDMRP-MB200024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗