NCT04084093撤回不适用
Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
Medline Industries2 个研究点 分布在 1 个国家开始时间: 2020年2月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Self-reported evaluation of subject pain perception during dressing changes using a numerical pain scale.
研究概览
简要总结
This will be an observational study evaluating subject's perception of pain to dressing changes during removal and application of a surfactant gel. Wound healing will also be monitored. Anxiety before dressing change will be measured using a burn specific pain anxiety scale. Study intervention will include cleansing the wound per the facility's standard of care, followed by applying the investigational product on the wound. This will be followed by placing an appropriate secondary dressing.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject should be an inpatient, per the Two-Midnight rule at the time of study initiation.
- •At the time of subject's admission in the hospital, duration of his or her burn wound should be < or equal to 24 hours.
- •Subject who has a partial thickness burn wound, or an indeterminate burn wound, or who has both these characteristics in the same wound, as determined by the site Principal Investigator.
- •Subject's wound included in this study, does not require any surgical intervention.
- •Subject is able and willing to comply with requirements of this trial protocol.
- •Voluntarily signed informed consent obtained before any trial-related procedures are performed.
- •Subject must be able to communicate effectively with study personnel.
- •Subject has burn total body surface area (TBSA) between 1-20%.
排除标准
- •Subjects with electrical or radiation burns.
- •Subjects who are pregnant, nursing or planning to become pregnant during the course of the study.
- •Subjects who have known allergies to any ingredients in the dressings used in the study.
- •Subjects taking opiates during the study duration.
- •Subjects with an active diagnosis of substance use disorder within the past six months.
- •Subjects with previously diagnosed issues with pain perception, including conditions such as peripheral neuropathy, if they will preclude accurate assessment of primary and secondary endpoints.
- •Subjects with an active infection prior to enrollment.
- •Subject has previous or current systemic disease(s) which, in the judgement of the investigator, is likely to interfere with treatment. Subjects with well-controlled diabetes mellitus (HbA1C<8.5) shall be permitted.
研究组 & 干预措施
Surfactant Gel
Experimental
干预措施: Surfactant Gel (Device)
结局指标
主要结局
Self-reported evaluation of subject pain perception during dressing changes using a numerical pain scale.
时间窗: Baseline to Day 30
The numerical pain scale will be from 0 to 10 with 0 being no pain at all and 10 being the worst pain ever possible. This is the numeric rating scale.
次要结局
- Measure percent change in epithelium as recorded by the clinician.(Baseline to Day 30)
- Measure percent change in necrotic tissue in the wound bed(Baseline to Day 30)
- Measure change in wound size(Baseline to Day 30)
- Measure anxiety using a burn specific anxiety scale(Baseline to Day 30)
研究者
研究点 (2)
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