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

NCT05462860 | Recruiting

• 2 other identifiers: SuprathelCDMRP-MB200024
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound of Skin; Burns

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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-reported perception of pain based on the Visual Analog Scale

  After initial application (Day 0) and weekly

Study Arms (2)

Suprathel® dressing

EXPERIMENTAL

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®

Standard of Care

ACTIVE COMPARATOR

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®

Interventions

Suprathel® OTHER

Application of standard of care dressing.®

Also known as: standard of care

Standard of Care; Suprathel® dressing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Metis Foundation: lead

Study Sites (1)

North Carolina Jaycee Burn Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

poly(lactide-co-trimethylenecarbonate-co-epsilon-caprolactone); Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rodney Chan, MD

  Metis Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Diaz, RN

CONTACT

2105691140; Diaz@metisfoundationusa.org

Kristin Anselmo

CONTACT

Anselmo@metisfoundationusa.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof of concept

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: September 18, 2024
• Primary Completion: December 29, 2025
• Study Completion (Estimated): June 29, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)