A Single Centre Comparison Study on Adhesion Properties of Three (3) Skin Adhesives on Healthy, Female, Adult Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ambu A/S
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Skin adhesion rating
研究概览
简要总结
This clinical investigation is a single centre, double blinded, case control study in healthy adult females. This study will be conducted in private rooms at Gentofte Hospital (Hjerte-medicinsk Forskning, post 835, Kildegårdsvej 28, 2900 Hellerup).
The investigation centre will enroll 39 subjects including a 20% drop out within a four (4) months period. The subject will not be enrolled before approval of investigation protocol by the local ethics committee.
The subjects need to meet the inclusion and exclusion criteria to be included in this clinical investigation. Each volunteer enrolled in the investigation can only participate once in a procedure. The testing period for each subject will be minimum 72 hours.
The principal investigator's qualifications will be verified through his/her CV. The principal investigator is required to be a medical doctor with at least one year's experience in using similar medical adhesives (e.g. by being experienced in using electrodes where medical adhesives are included) and at least one year's experience with clinical research. In addition, the investigator must be trained in GCP before the study is initiated.
If any subject withdraws from the study, they will not be replaced as drop-out rate is included in the sample size.
Subjects must show up for two sessions, in the first session six adhesives will be placed below the subjects bra. The adhesives will be removed after minimum 72 hours at the second visit. While wearing the adhesives the subjects must keep the investigational area dry. 24, 48 and 72 hours after placement of the adhesives, the subject is asked to completed a questionnaire.
The eCRF must be completed for each subject that has signed the Informed consent form (ICF) and enrolled into this clinical investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None (Participant, Investigator)
盲法说明
The one arm tested three adhesives in parallel in random positions on the trunk. Investigator and participants were however blinded to the randomization placement.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Healthy Volunteers.
- •Age 18 - 40 years old.
- •Willing to attend two scheduled visits
- •Able to assess itch and adherence at 24h, 48h and 72h.
- •Provide written informed consent.
排除标准
- •Non-intact skin barrier (e.g. eczema, rash, cut, scar tissue, wound, etc.).
- •History of inflammatory skin diseases (e.g. atopic dermatitis or psoriasis).
- •History of contact allergy
- •Swimming or engaging in sport activities causing sweat during study peri-od. v. Use of medication (e.g. corticosteroids) which could affect skin reactions.
研究组 & 干预措施
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.
干预措施: Application of adhesive (Other)
结局指标
主要结局
Skin adhesion rating
时间窗: Minimum 72 hours after application
Rate of adhesion on a 5-point scale (no lift off the skin to deattached and completely off the skin)
Number of Participants Who Achieved Adhesion Success After 72 Hours
时间窗: After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor
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). 1. = ≥75% to \<90% adhered (only some edges lift off the skin). 2. = ≥50% to \<75% adhered (less than half lifts off the skin). 3. = \>0% to \< 50% adhered (more than half lifts off the skin without falling off). 4. = 0% adhered (detached and is completely off the skin). A worst-case scenario was used, i.e. the least favourable, score of the two scores (there are two scores as there are two adhesives of each type on every subject) for each type of adhesive.
次要结局
- Ease of removal(Minimum 72 hours after application)
- Pain during removal of adhesive(Minimum 72 hours after application)
- Rate of skin reaction(Minimum 72 hours after application)
- Adhesive residue(Minimum 72 hours after application)
- Itch(24, 48 and 72 hours after adsive application)
- Number of Participants Experiencing Itchiness by the Adhesive at 24, 48 and 72 Hours(24, 48 and 72 hours after adhesive application)
- Rate of Ease of Removal of Adhesive After 72 Hours(After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor)
- Rate of Pain During Removal of Adhesive After 72 Hours(After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor)
- Rate of Skin Reaction After Wearing Adhesive for 72 Hours(After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor)
- Number of Participants With Adhesive Residue Left on Skin After Removal of Adhesive(After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor)