三种不同粘合剂的粘合性能研究
三 (3) 种皮肤粘合剂对健康成年女性志愿者的粘合特性的单中心比较研究
该临床研究是一项针对健康成年女性的单中心、双盲、病例对照研究。 这项研究将在根措夫特医院 (Hjerte-medicinsk Forskning, post 835, Kildegårdsvej 28, 2900 Hellerup) 的私人房间内进行。
调查中心将在四 (4) 个月内招募 39 名受试者，包括 20% 的辍学受试者。 在当地伦理委员会批准调查方案之前，不会招募受试者。
受试者需要满足纳入和排除标准才能纳入此临床研究。 每个参加调查的志愿者只能参加一次程序。 每个科目的测试时间至少为 72 小时。
主要研究者的资格将通过他/她的简历进行验证。 主要研究者必须是一名医生，具有至少一年使用类似医用粘合剂的经验（例如，具有使用包含医用粘合剂的电极的经验）和至少一年的临床研究经验。 此外，研究者必须在研究开始前接受 GCP 培训。
如果任何受试者退出研究，他们将不会被替换，因为退出率已包含在样本量中。
受试者必须出席两次会议，在第一次会议中，六个粘合剂将被放置在受试者胸罩下方。 粘合剂将在第二次访问时至少 72 小时后移除。 在佩戴粘合剂时，受试者必须保持研究区域干燥。 放置粘合剂后 24、48 和 72 小时，要求受试者完成问卷调查。
必须为已签署知情同意书 (ICF) 并参加此临床调查的每个受试者填写 eCRF。
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hellerup、丹麦、2900
- Gentofte Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
- 女性健康志愿者。
- 年龄 18 - 40 岁。
- 愿意参加两次预定的访问
- 能够在 24 小时、48 小时和 72 小时评估瘙痒和依从性。
- 提供书面知情同意书。
排除标准：
- 不完整的皮肤屏障（例如 湿疹、皮疹、割伤、疤痕组织、伤口等）。
- 炎症性皮肤病史（例如 特应性皮炎或牛皮癣）。
- 接触过敏史
- 学习期间游泳或从事导致出汗的体育活动。 v. 使用药物（例如 皮质类固醇）可能会影响皮肤反应。
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：All study participants
Each study participant will test two patches of each of three different experimental adhesives.
Six patches in total.
One set of each adhesive will be placed on the right side of the trunk while another set will be placed on the left side of the trunk.
The position of the three adhesives on each side are randomly allocated.
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Adhesive will be placed on the subjects skin on the trunk.
Placement of the adhesive will be randomized.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants Who Achieved Adhesion Success After 72 Hours
大体时间：After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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Did the adhesive stay attached to the skin for 72 hours (Yes/No). For the adhesive to be considered attached (yes) more than 75% adherence should be achieved. Rate of adhesion on a 5-point scale (no lift off the skin to detached and completely off the skin) 0 = ≥90% adhered (essentially no lift off the skin).
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After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours
大体时间：24, 48 and 72 hours after adhesive application
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Subject evaluation of itchiness caused by the adhesives at 24, 48, 72 hours measured on visual analogue scale (VAS) (0-10) 0 = 'No itch', 10 = Worst imaginable itch.
Adhesives when only including the worst score on each adhesive for each subject
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24, 48 and 72 hours after adhesive application
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Rate of Ease of Removal of Adhesive After 72 Hours
大体时间：After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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Ease of removal on 5-point scale (very difficult to very easy) ; 1: Very difficult; 2: Difficult; 3: Acceptable; 4: Easy; 5: Very easy.
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After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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Rate of Pain During Removal of Adhesive After 72 Hours
大体时间：After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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Subject evaluation of pain during removal of the adhesives measured on visual analogue scale (0-10).
0= no pain, 10 = Worst possible pain
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After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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Rate of Skin Reaction After Wearing Adhesive for 72 Hours
大体时间：After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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Skin reaction rated on a scale from 0-7 (no evidence of irritation to strong reaction spreading beyond the application site). 0: No evidence of irritation
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After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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Number of Participants With Adhesive Residue Left on Skin After Removal of Adhesive
大体时间：After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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The number of participants with any adhesive residue left on skin after removal of adhesive (yes/no) after 72 hours.
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After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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