A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin

Skin Abnormalities Clinical Trial

Official title:

A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05641168
• Other study ID #: CP333
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: November 2022
• Source: Coloplast A/S
• Contact: Michel Briand de Crevecoeur
• Phone: +4549111272
• Email: dkmibc[@]coloplast.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study investigates different adhesive materials on healthy and peristomal skin

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has given written consent
• Be at least 18 years of age and have full legal capacity
• Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients)

Exclusion Criteria:

• Currently receiving or have within the past 2 months received radio- and/or chemotherapy
• Currently receiving or have within the past month received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment
• Are pregnant or breastfeeding
• Having dermatological problems in the abdominal area (assessed by investigator)
• Participate in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol

Related Conditions & MeSH terms

• Skin Abnormalities

Intervention

Other:
• Adhesive material
Newly developed adhesive material
• Standard adhesive material
Standard adhesive material

Locations

Country	Name	City	State
Denmark	Coloplast Research Unit/Userlab	Humlebaek

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherent area	Adherent area (assessed by photos of adhesive materials)	At every material change throughout the study, an average of 1 week