An Open, Randomized, Comparative, Multi-centre Investigation Evaluating the Efficacy and Tolerance of Mepilex Ag Versus Silver Sulfadiazine in the Treatment of Deep Partial Thickness Burn Injuries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 9
- 主要终点
- Time to Healing
研究概览
简要总结
The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.
详细描述
Subjects enrolled in this investigation were in-patients at eleven centers in China. To be included, subjects had to have deep partial-thickness burn injuries. The subjects were consecutively allocated to a subject code providing they fulfilled all inclusion criteria and none of the exclusion criteria and had signed a written informed consent form. Two evaluators independent of each other made the judgment regarding depth of the burn before enrolling a subject. The subjects were randomized to either receive Mepilex Ag or SSD.
Treatment period were up to four weeks with either SSD or Mepilex Ag. Changes of the investigation products were performed according to a standardized schedule, unless the wound healed before.
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
- None
入排标准
- 年龄范围
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a deep partial-thickness burn injury covering 2.5%-25% TBSA (3rd degree areas not to exceed 10% TBSA)
- •Burn of thermal origin
- •Both gender with an age ≥5 years and ≤65 years at ICF
- •Understood and signed informed consent
- •Subjects who are younger than the legal consenting age must have a legally authorized representative
- •One study burn should be chosen which fulfil the following criteria;
- •isolated burn area (not head and/or face)
- •2nd degree deep partial
- •area is from 1 to 10% BSA
- •All deep 2nd degree burn should be treated with the investigation product, Mepilex Ag/SSD (according to the randomization).
排除标准
- •Burns "occurred" equal to or older than 36 hours
- •Burns of chemical and electrical origin
- •Clinically infected burn (as judged by the investigator)
- •Subjects with lung injury or subjects being on a ventilator
- •Treatment of the burn with an active agent before study entry. SSD is allowed up to 24 hours prior to randomization
- •Subjects with dermatologic skin disorders or necrotizing processes
- •Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment
- •Subjects with insulin dependent diabetes mellitus
- •Subjects treated with systemic glucocorticosteroids, except Subjects taking occasional doses or doses less than 10mg prednisolon (day or equivalent
- •Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
- •Known allergy/hypersensitivity to any of the components (SSD , Ag glycerin, monostearate, glycerol, cetearyl alcohol, leveling agent O, albolene, light liquid paraffin, ethylparaben/ silicone, polyurethane foam pad containing a silver compound, activated carbon)of the investigation products
- •Subjects with physical and/or mental conditions that are not expected to comply with the investigation
- •Participation in other clinical investigation(s) within 1 month prior to start of the investigation
- •Pregnancy (pregnancy test needed if they do not use contraceptive)
- •Previously randomized to this investigation (PUMA 418
研究组 & 干预措施
Mepilex Ag
Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.
干预措施: Mepilex Ag (Device)
Silver Sulphadiazine Ag cream
SSD Ag cream is white cream, 1% SSD Ag, 40g/tube This cream is indicated for prevent and treat secondary wound infection of small area, mild burn/scald.
干预措施: Silver Sulphadiazine Ag cream (Drug)
结局指标
主要结局
Time to Healing
时间窗: 4 weeks
Healing will be defined as number of days
次要结局
- Percent of Burn Epithelised/Healed(4 weeks)
- Number of Dressing Changes(4 weeks)
- % of Study Burn Healed After One Week(1 week)