North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Location contact
Booker King, MD
PRINCIPAL_INVESTIGATOR
Carter
CONTACT
NCT Number: NCT05462860
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
Location status: Recruiting
Booker King, MD
PRINCIPAL_INVESTIGATOR
Carter
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of standard of care dressing.®
Other names: standard of care
Time frame: 21 days
The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application.
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)
Incidence of infections and inflammatory response and scar development
Time frame: Mid (3-9 months) and long term (52 weeks)
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring.
Time frame: After initial application (Day 0) and weekly
Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) prior to and after application of the first dressing and subsequent dressings.
Contact information is provided by the study sponsor or research team.
The Metis Foundation
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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