Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing

Официальное название

Prospective Randomized Open Label Multicenter Phase IV Clinical Trial to Compare Transforming Powder Dressing (TPD) to Current Standard of Care (SOC) Dressing Therapies in Acute Partial Thickness Burn Wounds

Обзор

This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.

Подробное описание

This post-marketing study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing for burn wounds. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 36 hours prior to enrollment in the study) partial thickness burn wound, comprising less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed during hospitalization and then upon discharge from the hospital for up to 28 days after enrollment into the study. At each of the 8 study visits, the burn wound will be evaluated, photographed and measured. The wound will be cleaned and debrided, if needed, per usual standard burn care. A wound dressing will be applied using TPD or a typical SOC dressing. Wound healing and wound pain will be monitored at each visit, and the results of the two groups (TPD and SOC) will be compared to each other. A survey evaluating the satisfaction with the dressing received will be given at the end of the study, or when the wound heals, whichever comes first.

Вмешательства

• Устройство Altrazeal (R) Transforming Powder Dressing
  After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with Altrazeal TPD.
• Другое Standard of Care burn dressing
  After informed consent and the subject is determined to meet all selection criteria, randomization will occur in a 1:1 ratio, to determine the treatment arm of the study. Half of those randomized will receive burn care with the institution's standard of care burn dressing.

Первичные конечные точки

• Pain from the Burn Wound [Срок оценки: 28 days (or sooner if the wound heals prior to 28 days)]

Вторичные конечные точки (3)

• Wound healing [Срок оценки: 28 days (or sooner if the wound heals prior to 28 days)]
• Safety of the Interventions (TPD and SOC) [Срок оценки: 28 days (or sooner if the wound heals prior to 28 days)]
• Subject satisfaction [Срок оценки: End of Study]

Критерии участия

Критерии включения

• Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.
• Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old
• Wounds must be partial thickness, involving up to 20% of the total body surface area.
• Burn injury should be less than 72 hours old
• Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations.
• Willing and able to provide written informed consent.

Критерии исключения

• Known allergy to TPD or its components

• Women who are pregnant, breast feeding, or plan to get pregnant during the study period.
• Infected wounds
• Presence of any full thickness (third degree) burns
• Electrical burns
• Heavily draining burns due to underlying chronic lymphedema or other conditions
• Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.
• History of poor wound healing and/or skin/immune system condition

• Deemed by clinician not to be suitable
• Unwilling or not able to provide consent or comply with protocol or required visits
• Developmental disability/significant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol
• Active alcohol or substance abuse

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• University of California-Irvine — Orange
• MedStar Washington Hospital Center — Washington D.C.
• Jackson Memorial Hospital UM/JMH Burn Center — Miami
• University of Louisville Health — Louisville
• Westchester Medical Center — Valhalla
• University of Texas SW (Parkland) — Dallas

Идентификаторы

NCT: NCT05424354 · U-C-TPD-2021-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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