Field Shield Wound Dressing Study

Официальное название

Clinical Assessment of Field Shield Wound Dressing of Large Surface Area Burn Wounds

Обзор

This study is to compare the Field Shield Wound Dressing (FSWD) as a treatment for burn wounds to a standard of care burn wound dressing to evaluate healing, infection, pain/discomfort, and deepening of wound over time.

Подробное описание

To assess FSWD in comparison to standard of care dressing, subjects will undergo dressing changes and visual assessments.

Вмешательства

• Устройство Field Shield Wound Dressing
  Spray on wound dressing.
• Устройство Silverlon
  Silver dressing

Первичные конечные точки

• Wound closure [Срок оценки: From enrollment to end of study, 4-6 months.]

Вторичные конечные точки (6)

• Infection [Срок оценки: 35 days]
• Surgical debridement [Срок оценки: 35 days]
• Pain severity [Срок оценки: days 3, 7, 12, 19, and 28.]
• Scar [Срок оценки: day 35 and 4-6 months]
• Health-related quality of life [Срок оценки: day 35 and 4-6 months]
• Function [Срок оценки: Day 3, 35 and 4-6 months]

Критерии участия

Критерии включения

• Thermal injury size 5-30% TBSA
• Admitted to the burn center and enroll able within 72 hours of injury
• Subject has two distinct areas of 100cm2 or larger of intermediate to deep partial thickness burns (study sites). These areas are judged to be comparable in depth.
• The subject and or caregiver is able and willing to follow the protocol requirements
• Achieve wound photos and dressing change at 3 days

Критерии исключения

• Subject has congestive heart failure, oxygen-dependent chronic lung disease, end-stage renal disease, or liver cirrhosis

• Subject is undergoing hospice care.
• Subject is currently being treated for an active malignant disease
• Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety
• Known contraindications to silver metals, silver chloride, or silver tetraoxide
• Known contraindications to lidocaine
• Known allergies to any components of either primary dressing in the study
• Known allergies to the silicone or adhesives in secondary dressings
• Burns located on the hands, feet, face, and/or genitals will be excluded from treatment sites, but will be included in the total TBSA calculation
• Subject has a combined TBSA of 31% or greater of partial and/or full thickness burn wounds
• Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
• Subject is pregnant, breast feeding, or planning to become pregnant.
• Subjects who, within 60 days prior to enrollment, have a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, application of topical steroids within one month prior to enrollment, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
• Burn study site(s) has been previously treated with tissue engineered materials (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis, Matristem) preceding the study wound dressing application.
• Burn study site(s) has been previously treated with a silvadene

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Valleywise Health — Phoenix
• United State Army Institute of Surgical Research — San Antonio

Идентификаторы

NCT: NCT07337616 · 20240572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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