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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Suprathel®
  Application of standard of care dressing.®

Первичные конечные точки

• Need for autograft application [Срок оценки: 21 days]

Вторичные конечные точки (3)

• Wound infection rate, wound closure of the region [Срок оценки: 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). [Срок оценки: Mid (3-9 months) and long term (52 weeks)]
• Patient-reported perception of pain based on the Visual Analog Scale [Срок оценки: After initial application (Day 0) and weekly]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• North Carolina Jaycee Burn Center — Chapel Hill

Идентификаторы

NCT: NCT05462860 · Suprathel · CDMRP-MB200024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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