Trial Outcomes & Findings for Evaluation of the Peel Force of New Adhesives From the Skin (NCT NCT03200444)

Last Updated: 2025-04-25

Results Overview

The peel force (N) needed to peel off adhesive strips from the skin

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

30 min

Results posted on

2025-04-25

Unit of analysis: Number of strips

Participant milestones
Measure	Standard Adhesive 1 This strip consists of a standard hydrocolloid adhesive found in ostomy products	Standard Adhesive 2 This strip consists of a standard hydrocolloid adhesive found in ostomy products	Standard Adhesive 3 This strip consists of a standard hydrocolloid adhesive found in ostomy products	P-4 Adhesive Newly developed adhesive	P-15 Adhesive Newly developed adhesive	P-16 Adhesive Newly developed adhesive
Overall Study STARTED	6 6	6 6	6 6	6 6	6 6	6 6
Overall Study COMPLETED	6 6	6 6	6 6	6 6	6 6	6 6
Overall Study NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0

Withdrawal data not reported

Evaluation of the Peel Force of New Adhesives From the Skin

Baseline characteristics by cohort
Measure	Testing of 6 Adhesive Strips n=6 Participants Each subject tests six adhesive strips on pre-striped skin. 1. Standard adhesive 1 2. standard adhesive 2 3. Standard adhesive 3 4. P-4 5. P-15 6. P-16 The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits. Standard adhesive 1: This strip consists of a standard hydrocolloid adhesive found in ostomy products Standard adhesive 2: This strip consists of a standard hydrocolloid adhesive found in ostomy products Standard adhesive 3: This strip consists of a standard hydrocolloid adhesive found in ostomy products P-4: Newly developed adhesive P-4 P-15: Newly developed adhesive P-14 P-16: Newly developed adhesive P-8
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment Denmark	6 participants n=5 Participants

Timeframe: 30 min

Population: All participants were analysed

The peel force (N) needed to peel off adhesive strips from the skin