A Pilot Evaluation Exploring New Adhesive Materials and T... | NCT05641168

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

NCT05641168

Sponsor

Coloplast A/S

Status

Completed

Last Update Posted

Sep 4, 2025Actual

Enrollment

114Actual

Phase

Not Applicable

Conditions

Skin Abnormalities

Interventions

Adhesive material
Standard adhesive material

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2021Actual

Primary Completion Date

May 30, 2024Actual

Completion Date

May 30, 2024Actual

First Submitted Date

Nov 15, 2022

First Submission Date that Met QC Criteria

Nov 29, 2022

First Posted Date

Dec 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2025

Last Update Posted Date

Sep 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ostomy Adhesive material	Experimental	Newly designed ostomy adhesive material	Other: Adhesive material
comparator adhesive material	Other	Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product	Other: Standard adhesive material

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adhesive material	Other	Newly developed adhesive material	Ostomy Adhesive material

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	May 28, 2026
Reset	Jun 23, 2026

Condition Browse Module

MeSH Terms

ID	Term
D012868	Skin Abnormalities

Ancestor Terms

ID	Term
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000269	Adhesives

Ancestor Terms

ID	Term
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 28, 2026			Jun 23, 2026
Jul 1, 2026