Measurement and Comparison of the Occlusive and Hydrating Capacity of Three Silicone Gels: BAP Scar Gel, Dermatix, Kelocote and One Gel- Cream: Alhydran
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The occlusive and hydrating capacity of the products.
研究概览
简要总结
Study hypothesis: Is Alhydran gel-cream as efficient as silicone gel for skin occlusion and hydration?
For this study 16 volunteers and ten patients with healed full thickness burns will be included.
After a short period of acclimatization four test areas will be determined. For healthy volunteers the standard zones are located on the inner forearm, two on each forearm.
For patients with healed burns the 4 test zones are located on either the healed donor site or the healed skin grafted area.
In each test zone baseline measurements will be taken before application of the products.After application of the three silicone gels and the hydrating gel cream the trans epidermal water loss (TEWL) and the moisture content of the stratum corneum will be measured by using the TEWAmeter®TM300 and the Corneometer® CM825 (Courage & Khazaka).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •healthy volunteers or patients with healed full thickness burns and donor sites
- •not pregnant
- •age>18 years
- •male or female
- •written authorisation of the patient or volunteer is required.
排除标准
- 未提供
研究组 & 干预措施
Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
干预措施: Dermatix (Drug)
Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
干预措施: Kelocote (Drug)
Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
干预措施: BAP scar gel (Drug)
Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
干预措施: Alhydran (Drug)
Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
干预措施: Bap Scar Care T (Drug)
Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
干预措施: Bap Scar Care S (Drug)
Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
干预措施: Mepiform (Drug)
Patients and healthy volunteers
Patients with healed full thickness burns and healthy volunteers will be included in the study
干预措施: Scar Ban Elastic (Drug)
结局指标
主要结局
The occlusive and hydrating capacity of the products.
时间窗: 1 hour after application
Measurements will be done by using the TEWAmeter® for measurement of the Trans Epidermal Waterloss and the Corneometer® 825CM for measurement of the moisture content of the stratum corneum (Courage \& Khazaka). For this study no risk factors are determined.
次要结局
- The occlusive and hydrating capacity of the products.(3 hours after application)