Study on Adhesion Properties of Three Different Adhesives

NCT04125797 | Completed Results

• 1 other identifier: CIS-015
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved Adhesion Success After 72 Hours

  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.

  After a minimum of 72 hours (no more than 3 days) after application the adhesives will be removed and assessed by a medical doctor

Secondary Outcomes (5)

• 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

Study Arms (1)

All study participants

EXPERIMENTAL

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.

Other: Application of adhesive

Interventions

Application of adhesive OTHER

Adhesive will be placed on the subjects skin on the trunk. Placement of the adhesive will be randomized.

All study participants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ambu A/S: lead

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Results Point of Contact

• Title: Saraswathy
• Organization: Ambu A/S

sygn@ambu.com

+6012-5244540

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The one arm tested three adhesives in parallel in random positions on the trunk. Investigator and participants were however blinded to the randomization placement.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 14, 2019
• Study Start: October 7, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: July 22, 2026
• Results First Posted: July 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)