跳至主要内容
临床试验/NCT02818257
NCT02818257已完成不适用

An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

Coloplast A/S1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Coloplast A/S
入组人数
27
试验地点
1
主要终点
Peel force used to removed adhesive

研究概览

简要总结

The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
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

  • •Have given written informed consent
  • •Be at least 18 years of age and have full legal capacity
  • •Have intact skin on the area used in the investigation

排除标准

  • •Currently receiving or have within the past 2 month received radio- and/or chemotherapy
  • •Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
  • •Are pregnant or breastfeeding
  • •Having dermatological problems in the abdominal area (assessed by investigator)
  • •Participate in other clinical investigations or have previously participated in this investigation

研究组 & 干预措施

Strip A (wet)

Experimental

Six strips of Strip A are applied on skin wetted with two different buffers (3 strips each)

干预措施: Strip A (Other)

Strip A (dry)

Experimental

Six strips of Strip A are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)

干预措施: Strip A (Other)

Strip B (wet)

Experimental

Six strips of Strip B are applied on skin wetted with two different buffers (3 strips each)

干预措施: Strip B (Other)

Strip B (dry)

Experimental

Six strips of Strip B are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)

干预措施: Strip B (Other)

Strip C (wet)

Experimental

Six strips of Strip C are applied on skin wetted with two different buffers (3 strips each)

干预措施: Strip C (Other)

Strip C (dry)

Experimental

Six strips of Strip C are applied on skin that is either dry (3 strips) or wetted with buffer (3 strips)

干预措施: Strip C (Other)

结局指标

主要结局

Peel force used to removed adhesive

时间窗: 60 min

The three strips applied to skin that has received the same treatment (either buffer 1, buffer 2 or dry) are removed at three different time points (max 60 min) and the peel force is measured. Peel force (90 degree angle from skin) The tensile tester was mounted on a tripod under which the subject was lying. In this way the tensile tester measures the force (Newton), which was needed to remove the adhesive from the skin with a constant speed and with a mean angel of 90°

次要结局

未报告次要终点

研究者

发起方
Coloplast A/S
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验