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Набор скоро начнётся NCT07453732

Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients.

Без фазы С лечением Partial-thickness Burn Pain Second Degree Burn

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: Banana leaf dressing.
Кому может быть актуально
Состояния в реестре: Partial-thickness Burn, Pain, Second Degree Burn. Базовые параметры: 18 лет — 99 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pilot Study of Banana Leaves as a Primary Wound Dressing for Partial Thickness Burn Wounds

Обзор

This study plans to look at the benefits of banana leaves as a primary burn wound dressing. Study patients will be compared to historical patients

Подробное описание

Historically, banana leaves have been used as a burn wound dressing in developing countries. Current literature on banana leaf dressings is limited to predominantly pediatric patients and surgical wounds (i.e. skin graft donor sites). The comparison dressing is often other non-standard burn dressings (e.g. boiled potato peel bandage) and these studies are almost exclusively performed in tropical locations where banana plants grow naturally (Africa and Asia). To date, no study on the effectiveness of banana leaf dressings has been done in the United States, nor has there been a focus on their effectiveness in second degree partial thickness burns. Our pilot study aims to establish the feasibility of using banana leaf dressings for second degree partial thickness burn wounds in adult patients, in a geographic location that does not support natural banana agriculture.

Вмешательства

  • Устройство Banana leaf dressing
    Sterilized banana leaf as a primary non-adherent burn dressing

Первичные конечные точки

  • Pain scores, as measured using Number Pain Rating Scale [Срок оценки: Before, during and after each wound care session during hospitalization, approximately 14 days]
Вторичные конечные точки (5)
  • Total use of opioids and benzodiazepines during wound care sessions [Срок оценки: During hospitalization, approximately 14 days]
  • Time to wound closure [Срок оценки: During hospitalization or at follow-up in clinic, approximately within 1 month]
  • Skin graft rate [Срок оценки: During hospitalization, approximately 14 days]
  • Burn wound infection rate [Срок оценки: During hospitalization, approximately 14 days]
  • Number of participants with at least one adverse event [Срок оценки: End of study (1 year)]

Критерии участия

Критерии включения

  • <10% Total body surface area (TBSA) partial thickness burns
  • Patients age 18 to 99
  • Primary admission (inpatient) to the UCHealth Burn and Frostbite Center
  • Burns <48 hours old on admission

Критерии исключения

  • Patients <18 years
  • Patients who are pregnant, incarcerated, or cognitively impaired
  • Burns >48 hours old on admission
  • Patients with concurrent traumatic injuries
  • Patients with chemical, electrical, or friction burns
  • Full thickness burns
  • Burns to sensitive areas: face, genitals, hands, feet
  • Burns with evidence of infection on admission
  • Patients with a known allergy to bananas or latex
  • Patients with opioid use disorder or methamphetamine use disorder

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Colorado Hospital — Aurora

Публикации

  • Chendake S, Kale T, Manavadaria Y, Motimath AS. Evaluation of Banana Leaves (Musa paradisiaca) as an Alternative Wound Dressing Material Compared to Conventional Petroleum Jelly Gauze Dressing in Contused, Lacerated and Sutured Wounds Over the Head, Neck and Face Region. Cureus. 2021 Oct 6;13(10):e18552. doi: 10.7759/cureus.18552. eCollection 2021 Oct. PMID 34765339
  • Guenova E, Hoetzenecker W, Kisuze G, Teske A, Heeg P, Voykov B, Hoetzenecker K, Schippert W, Moehrle M. Banana leaves as an alternative wound dressing. Dermatol Surg. 2013 Feb;39(2):290-7. doi: 10.1111/dsu.12067. Epub 2012 Dec 10. PMID 23387359
  • Srinivas CR, Sundaram VS, Raju BA, Prabhu SK, Thirumurthy M, Bhaskar AC. Achieving asepsis of banana leaves for the management of toxic epidermal necrolysis. Indian J Dermatol Venereol Leprol. 2006 May-Jun;72(3):201-2. doi: 10.4103/0378-6323.25779. PMID 16766833
  • Gore MA, Akolekar D. Evaluation of banana leaf dressing for partial thickness burn wounds. Burns. 2003 Aug;29(5):487-92. doi: 10.1016/s0305-4179(03)00050-0. PMID 12880731
  • Gore MA, Akolekar D. Banana leaf dressing for skin graft donor areas. Burns. 2003 Aug;29(5):483-6. doi: 10.1016/s0305-4179(03)00049-4. PMID 12880730
  • Dharnidharka VR, Kandoth PW. Use of banana leaves in Stevens-Johnson syndrome. Pediatr Dermatol. 1994 Sep;11(3):280-1. doi: 10.1111/j.1525-1470.1994.tb00606.x. No abstract available. PMID 7971569
  • Hop MJ, Polinder S, van der Vlies CH, Middelkoop E, van Baar ME. Costs of burn care: a systematic review. Wound Repair Regen. 2014 Jul-Aug;22(4):436-50. doi: 10.1111/wrr.12189. PMID 25041616

Идентификаторы

NCT: NCT07453732 · 25-2297

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗