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临床试验/NCT07453732
NCT07453732尚未招募不适用

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

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Pain scores, as measured using Number Pain Rating Scale

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • <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

排除标准

  • 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

研究组 & 干预措施

Banana leaf dressing

Experimental

Participants will be treated with banana leaf as a primary non-adherent dressing on their burn wounds

干预措施: Banana leaf dressing (Device)

结局指标

主要结局

Pain scores, as measured using Number Pain Rating Scale

时间窗: Before, during and after each wound care session during hospitalization, approximately 14 days

The Numeric Pain Rating Scale is a unidimensional subjective measure of pain intensity in adults, consisting of a scale from 0 to 10, where 0 represents "no pain" and 10 represents "worst pain imaginable" (or "worst possible pain").

次要结局

  • Total use of opioids and benzodiazepines during wound care sessions(During hospitalization, approximately 14 days)
  • Time to wound closure(During hospitalization or at follow-up in clinic, approximately within 1 month)
  • Skin graft rate(During hospitalization, approximately 14 days)
  • Burn wound infection rate(During hospitalization, approximately 14 days)
  • Number of participants with at least one adverse event(End of study (1 year))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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