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临床试验/NCT04880655
NCT04880655已完成不适用

A Randomized, Controlled Study Evaluating a Surfactant-based Wound Dressing for Tissue Salvage and Reduction in Surgical Burden

University of Tennessee1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Percent difference (cm2) in partial-thickness wound conversion

研究概览

简要总结

The purpose of this study is to test the following hypotheses:

  1. Early use of water-soluble surfactant dressing (WSD) on partial-thickness burn wounds will result in tissue salvage and reduce surgical burden.
  2. Early use of WSD on partial-thickness burn wounds will result in faster healing.
  3. Use of WSD on partial-thickness burn wounds will result in less painful wound care.
  4. Early use of WSD on partial-thickness burn wounds will result in less infection.
  5. Early use of WSD on partial-thickness burn wounds will result in lower hospital costs.

详细描述

Surfactant-based wound dressings have been utilized in chronic, non-healing wounds and small burn wounds to soften and aid removal of wound debris. In vitro data suggest enhanced healing properties are due the ability to stabilize and potentially reseal plasma membranes, thereby, retaining cellular integrity and enhance wound healing. Improved cellular viability and functionality has also been established in heat-shock, ionizing radiation, and electrical injury models. In one rat model, topically suffused mesentery demonstrated improved microvascular flow and reduction in the number of abnormally flowing microvessels following thermal injury. Intravenous administration has been studied in several disease states. In thermal injury, intravenous administration has shown potential to improve blood flow and reduce the zone of coagulation. Further, surfactant-based wound dressings are non-ionic and may facilitate removal, sensitize, or prevent bacterial biofilms. Biofilms are an evolved, protective mechanism bacteria utilize to reduce antimicrobial efficacy. Removal or penetration of biofilms is essential for bacterial eradication. There is little evidence demonstrating the efficacy of early use of a WSD for treating partial-thickness burn wounds.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •age ≥ 18 years old
  • •admitted within 24 hours of injury
  • •partial-thickness burn wounds on at least two non-contiguous areas of < 10% TBSA each and not involving face, fingers, toes, and perineum
  • •initial management assessed to require inpatient care

排除标准

  • •chemical, electrical, or inhalation injury
  • •incarcerated
  • •TBSA ≥ 20%
  • •wound expected to heal within 7 days
  • •patient or authorized representative unable or unwilling to consent
  • •unable to consent within 24 hours of injury

研究组 & 干预措施

Intervention

Experimental

Dressed with WSD and petrolatum gauze

干预措施: WSD (Device)

Control

Active Comparator

Dressed with bacitracin and petrolatum gauze

干预措施: Dressed with bacitracin and petrolatum gauze (Device)

结局指标

主要结局

Percent difference (cm2) in partial-thickness wound conversion

时间窗: Up to 14 days

Tissue salvage

次要结局

  • Daily pain scores for each wound care session(Up to 7 days)
  • Time to 95% re-epithelialization(Up to 28 days)
  • Incidence of burn wound infection and cellulitis(Up to 28 days)
  • Hospital costs(Up to 28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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