RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-18
Study Completion:2025-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05462860

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female ≥18 years and ≤75 years
  2. * Acute partial thickness burns by friction, contact, scalding from hot liquids and flame
  3. * TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet
  4. * TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)
  5. * Subject is able and willing to sign Informed Consent or via legally authorized representative
  1. * Study Wound due to electrical, radioactive, or frostbite-related injury
  2. * Infection of wounds in the study area at admission per Investigator or treating physician discretion
  3. * Pregnancy/lactation
  4. * Subjects who are unable to follow the protocol or who are likely to be non-compliant
  5. * Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study
  6. * Prisoners
  7. * Life expectancy less than 6 months
  8. * Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment

Contacts and Locations

Study Contact

Victoria Diaz, RN
CONTACT
2105691140
Diaz@metisfoundationusa.org
Kristin Anselmo
CONTACT
Anselmo@metisfoundationusa.org

Principal Investigator

Rodney Chan, MD
PRINCIPAL_INVESTIGATOR
Metis Foundation

Study Locations (Sites)

North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: The Metis Foundation

  • Rodney Chan, MD, PRINCIPAL_INVESTIGATOR, Metis Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-18
Study Completion Date2025-09-29

Study Record Updates

Study Start Date2024-09-18
Study Completion Date2025-09-29

Terms related to this study

Additional Relevant MeSH Terms

  • Wound of Skin
  • Burns