NCT01534858已完成不适用
A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 6
- 主要终点
- Graft neo-epithelisation
研究概览
简要总结
The purpose of this study is to evaluate the healing of split thickness skin grafts when treated with Prontosan® Wound Gel X in patients with partial and full thickness skin burns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Partial of full thickness burns requiring split thickness grafts
- •Target burn wound size 10cm2-1000cm2
- •Age ≥ 18 years
- •Ability to read, write and speak German.
- •Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent approved by the Institutional Ethics Committee (IEC) prior to all evaluations. Informed consent will be obtained from the patient or by a legal representative if the patient is not able/competent to consent. In this case, informed consent will be also obtained by the patient when he/she regains competence.
- •Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e. g. oral contraceptive, IUD, intra-muscular contraceptive, abstinence).
排除标准
- •Target wound has exposed hyaline cartilage
- •Connective tissue disorder
- •Previous skin graft failure at target wound site
- •Total burn surface area ≥ 70%
- •Infected target wound
- •Immunosuppression therapy
- •Chronic hemodialysis
- •Steroid use
- •Diabetes (Type I)
- •Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X
- •Allergy or sensitivity to chlorhexidine
- •Pregnancy
- •Simultaneous participation in another clinical trial
结局指标
主要结局
Graft neo-epithelisation
时间窗: 29 days
Wound infection
时间窗: 29 days
Need for re-operation of target wound site
时间窗: 29 days
Time to complete epithelization
时间窗: 29 days
次要结局
- Pruritis(29 days)
- Erythema(29 days)
- Pain(29 days)
研究者
研究点 (6)
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