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Assessement of the Peal Force Needed to Peel New Adhesives From the Skin

A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Handle Moisture From Abdominal and Peristomal Skin

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03289013
Enrollment
5
Registered
2017-09-20
Start date
2017-09-11
Completion date
2017-12-21
Last updated
2018-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy - Stoma

Brief summary

This study investigates the adhesion of new adhesives to the skin.

Interventions

This strip consists of a standard hydrocolloid adhesive found in ostomy devices

This strip consists of a standard hydrocolloid adhesive found in ostomy devices

OTHERLT-2

Newly developed adhesive

OTHERLT-21

Newly developed adhesive

OTHERLT-25

Newly developed adhesive

OTHER33-20

Newly developed adhesive

Sponsors

Coloplast A/S
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have intact skin on the area used in the investigation

Exclusion criteria

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy 2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment. 3. Are pregnant or breastfeeding 4. Have dermatological problems in the abdominal area (assessed by investigator)

Design outcomes

Primary

MeasureTime frameDescription
Swelling of the adhesive21 days1\. Swelling of adhesive strips measured by weight (Difference between weight of strip before and after test)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026