An Open, Non Controlled, Multi-centre, Clinical Investigation to Evaluate Efficacy in Partial Thickness (Superficial, Deep and Mixed) Second Degree Burns When Using a Soft Silicone, Silver Containing, Wound Contact Layer, Mepitel Ag.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 12
- 主要终点
- Number of Subjects Healed at Day 14.
研究概览
简要总结
Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.
详细描述
see Brief summary
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA
- •Study site is from 1-15% BSA
- •Study site is a single, isolated burn area
- •From 2 years and above
- •Thermal burn injury
- •Signed Informed Consent/Assent Form
- •Subjects who are younger than the legal consenting age must in addition to their own Assent form have a signature from a legally authorized representative.
排除标准
- •Completely non-exuding or dry wound bed at study site
- •Full thickness >5%
- •Burn greater than 24 hrs old
- •Burns to face or neck
- •Suspicion of infection of study burn
- •Use of chemical/enzymatic and biological debridement within 7 days of investigation start
- •Chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, Pemphigus) and hx of Steven Johnson or TENS disease
- •Subject with lung injury or subject being on a ventilator
- •Subject with dermatologic skin disorders or necrotizing processes
- •Subject with insulin dependent diabetes mellitus
- •Electrical, chemical etiology
- •Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment
- •Non-compliant subject
- •Subject previously included in this investigation
- •Subject included in other ongoing clinical investigation at present or during the past 30 days.
结局指标
主要结局
Number of Subjects Healed at Day 14.
时间窗: Healing will be assessed after 14 days.
\> = 95 % epitheliazation
Proportion of Subjects Healed at Day 21.
时间窗: Healing will be assessed after 21 days.
The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.
次要结局
- Percent of Study Burn Healed.(At day 21)