Using Suprathel® to improve healing of burn wounds and reduce grafting needs
Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
This study is testing if a special wound dressing called Suprathel® can help heal burn wounds better and reduce the need for skin grafts in people with partial thickness burns.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Metis Foundation Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05462860 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Suprathel®, a synthetic wound dressing, in promoting healing of acute partial thickness burns compared to standard care. The research focuses on its potential to reduce pain, infection rates, provider workload, scar development, and overall treatment costs. Participants will be treated with Suprathel® in a setting that simulates large-scale combat operations, where ease of application and portability are crucial. The study aims to provide evidence for the use of Suprathel® in burn management, particularly in challenging environments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with acute partial thickness burns covering at least 2% of their total body surface area.
Not a fit: Patients with burns from electrical, radioactive, or frostbite injuries, or those with infections in the study area, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing outcomes for burn patients and reduce the need for surgical grafting.
How similar studies have performed: Previous studies have shown promising results with similar synthetic dressings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- North Carolina Jaycee Burn Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Rodney Chan, MD — Metis Foundation
- Study coordinator: Victoria Diaz, RN
- Email: Diaz@metisfoundationusa.org
- Phone: 2105691140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.