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

The Metis Foundation

Status: Enrolling

Conditions: Wound of Skin; Burns

Treatments: Other: Suprathel®

Study type: Interventional

Funder types: Other

Identifiers

NCT05462860

Suprathel

CDMRP-MB200024 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Suprathel® dressing

Experimental group

Description:

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

Treatment:

Other: Suprathel®

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Suprathel®