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

Primary Purpose

Skin Abnormalities

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Adhesive material
Standard adhesive material
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Skin Abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Coloplast Research Unit/UserlabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ostomy Adhesive material

comparator adhesive material

Arm Description

Newly designed ostomy adhesive material

Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product

Outcomes

Primary Outcome Measures

Adherent area
Adherent area (assessed by photos of adhesive materials)

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
November 29, 2022
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05641168
Brief Title
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
Official Title
A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study investigates different adhesive materials on healthy and peristomal skin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Abnormalities

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ostomy Adhesive material
Arm Type
Experimental
Arm Description
Newly designed ostomy adhesive material
Arm Title
comparator adhesive material
Arm Type
Other
Arm Description
Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product
Intervention Type
Other
Intervention Name(s)
Adhesive material
Intervention Description
Newly developed adhesive material
Intervention Type
Other
Intervention Name(s)
Standard adhesive material
Intervention Description
Standard adhesive material
Primary Outcome Measure Information:
Title
Adherent area
Description
Adherent area (assessed by photos of adhesive materials)
Time Frame
At every material change throughout the study, an average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel Briand de Crevecoeur
Phone
+4549111272
Email
dkmibc@coloplast.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Louise Oemann Mohr
Email
dkmlom@coloplast.com
Facility Information:
Facility Name
Coloplast Research Unit/Userlab
City
Humlebaek
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lene Feldskov
Phone
+4549111888

12. IPD Sharing Statement

Learn more about this trial

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

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