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Идёт набор NCT05000983

A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries

Фаза I / Фаза II С лечением Burns

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PluroGel, Standard dressing.
Кому может быть актуально
Состояния в реестре: Burns. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Between Patient, Pilot Randomized Controlled Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries

Обзор

Burn injuries can result in long term physical and mental sequelae, not only from the scarring but also the painful dressings. The standard of care today remains use of antibiotic topical dressings while awaiting demarcation of the burn depth, with surgical excision and grafting for deep partial thickness and full thickness areas. Demarcation can be appreciated on admission for full thickness burns but is often a prolonged process that can last weeks. The clinical evaluation of the depth of the burn is a complex decision that often is made more challenging by the presence of the proteinaceous pseudoeschar and the coagulated dermis itself. Surgical debridement is relatively 'coarse' and by its very nature requires removal of a thin layer of viable tissue to reach the level that is vascularized enough to support a skin graft. There has been growing interest in the use of adjuncts to reduce the amount tissue debrided and potentially reduce the need for surgery itself. Operatively, there have been some reports that use of hydro-dissection devices (Versajet™) may allow a more controlled debridement, resulting in less viable tissue being sacrificed. There is also a growing experience with enzymatic debridement, especially with Bromolein, derived from Pineapple (NexoBrid®). Neither of these have been shown to definitively improve care in randomized controlled trials, (RCTs) and there is suggestion that in some settings may actually cause harm.

Подробное описание

Burn injuries can result in long term physical and mental sequelae, not only from the scarring but also the painful dressings. The standard of care today remains use of antibiotic topical dressings while awaiting demarcation of the burn depth, with surgical excision and grafting for deep partial thickness and full thickness areas. Demarcation can be appreciated on admission for full thickness burns but is often a prolonged process that can last weeks. The clinical evaluation of the depth of the burn is a complex decision that often is made more challenging by the presence of the proteinaceous pseudoeschar and the coagulated dermis itself. Surgical debridement is relatively 'coarse' and by its very nature requires removal of a thin layer of viable tissue to reach the level that is vascularized enough to support a skin graft. There has been growing interest in the use of adjuncts to reduce the amount tissue debrided and potentially reduce the need for surgery itself. Operatively, there have been some reports that use of hydro-dissection devices (Versajet™) may allow a more controlled debridement, resulting in less viable tissue being sacrificed. There is also a growing experience with enzymatic debridement, especially with Bromolein, derived from Pineapple (NexoBrid®). Neither of these have been shown to definitively improve care in randomized controlled trials, (RCTs) and there is suggestion that in some settings may actually cause harm.

A relatively recent entry into the 'space' of non-surgical burn wound debridement is Plurogel®. Unlike Bromolein, Plurogel® is a concentrated surfactant in the form of a stable, viscous gel. Each micelle has a hydrophilic outer surface that softens and loosens wound debris, and a hydrophobic inner core that traps debris. The micelles link to form a matrix that continually expands and contracts. This creates a cleansing/rinsing action that disrupts the surface tension holding slough and necrotic tissue in place. PluroGel® helps in creating a moist wound healing environment, which softens, loosens and drives slough and necrotic debris away from the wound bed, promoting autolytic debridement. PluroGel® is approved for use in burn injuries in Canada, however there are no randomized control trials (RCTs) to support its use. As Plurogel® appears to fill a much-needed niche in burn wound care, and as our centre seeks to be innovative in patient care, we trialed Plurogel® on some of our appropriately consented burn patients. The anecdotal experience is that the eschar lifted within about a week and there was visible wound healing. Healing time appeared to be reduced as the product would gently debride while still providing a moist wound bed encouraging wound healing. Team members began to value the new product. This early positive experience is the impetus for us to embark on a pilot RCT to provide evidence for us to continue to use this product.

Вмешательства

  • Препарат PluroGel
    A 0.5 cm layer of PluroGel® followed by the above standard dressing. In addition, this will be covered with moistened gauze, kept moist twice daily. (The additional factors are the use of PluroGel® and moistened gauze. Standard dressing will continue to be used.)
  • Препарат Standard dressing
    Topical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).

Первичные конечные точки

  • Primary outcome [Срок оценки: 1-14 days]
Вторичные конечные точки (3)
  • Patient and caregiver satisfaction and perception of pain [Срок оценки: At each dressing change]
  • Proportion requiring surgery [Срок оценки: 1-14 days]
  • Relative surface area skin grafted [Срок оценки: 1-14 days]

Критерии участия

Критерии включения

  • Persons with partial thickness face burns or unilateral limb burn injuries requiring admission.

Критерии исключения

  • Total burn surface area (TBSA) >30%.
  • Burn depth full thickness or deeper on initial assessment.
  • Prior excision at another healthcare centre.
  • Patients with pre-existing malnutrition
  • Electrical, chemical or other unusual burn etiologies

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

Канада · 1 центр
  • University of Manitoba — Winnipeg

Идентификаторы

NCT: NCT05000983 · between

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗