A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
研究概览
简要总结
AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of Hydrofiber® (NaCMC). This dressing product was launched in 2012. A new source of silicone adhesive is now under assessment for this product. This Healthy Volunteer Wear test will form part of the Design Validation for this change in supplier and is required to confirm that the new Silicone Adhesive trilaminate supplier can coat the silicone adhesive to provide comparable adhesive dressing performance in terms of wear time, ease of use and with a similar safety profile in relation to the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Investigator)
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
- •Provide written informed consent
- •Be a healthy volunteer and be over 18 years of age
- •Be willing to attend two scheduled visits for application and removal of the device and adverse event review
- •Have healthy unbroken skin
排除标准
- •Subjects with a history of sensitivity to any one of the components of the device being studied
- •Female subjects who are currently pregnant or lactating
- •Subjects who are not willing and able to attend the 'clinic' for the required assessments
- •Subjects with excessive hair on their backs
- •Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
结局指标
主要结局
Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
时间窗: 7 days
* Adhesion at 7 days measured by: 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Conformability 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Dressing Integrity 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Ease of Application 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Ease of Removal, 1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult * Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable * Comfort during removal 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor * Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction)
次要结局
- Safety - the Nature and Frequency of Adverse Events(7 days)