NCT01530087

Terminated

Preliminary Evaluation of CASTLE Barrier Prototype UK

Hollister Incorporated Source

Hollister Incorporated

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

4518-O

Secondary identifiers

CIV-GB-11-07-001241

REGISTRY · Eudamed

Study Type

interventional

Actual enrollment (reported)

3

Locations

1 country

Sites

1

Timeline

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2012

Actual (reported)

Study Completion

August 2012

Actual (reported)

Brief Summary

The purpose of this study is to provide preliminary assessment of the safety and performance of a novel barrier formulation (CASTLE) in a small population of subjects with irritated peristomal skin.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 3 participants
Study completion date: August 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
February 2012
Actual (reported)
First Submitted
February 7, 2012
Actual (reported)
First Posted
February 9, 2012
Actual (reported)
Study Completion
August 2012
Actual (reported)
Results Posted
March 22, 2016
Actual (reported)

Last Updated: March 22, 2016
Status Verified: September 2015
Results QC Date: February 22, 2016
Last Update Submitted: February 22, 2016

Conditions

Peristomal Skin Complication

Keywords

colostomyileostomyirritant dermatitistwo piece barrier

Outcome Measures

Primary Outcomes (1)

Peristomal Skin Condition
mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)
1 - 30 days

Secondary Outcomes (1)

Security
30 days

Study Arms (1)

Treatment

EXPERIMENTAL

CASTLE Barrier

Device: CASTLE barrier

Interventions

CASTLE barrierDevice

Prototype barrier to be used in place of current two piece device

Treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

at least 18 years of age
has colostomy or ileostomy

Sponsors & Collaborators

Hollister Incorporated
Industrylead

Study Sites (1)

York Teaching Hospital

York, YO31 8HE, United Kingdom

MeSH Terms

Conditions

Dermatitis, Irritant

Condition Hierarchy (Ancestors)

Dermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Results Point of Contact

Title: Director, Global Clinical Affairs
Organization: Hollister Incorporated

Study Officials

Richard Murahata, PhD
Hollister Incorporated
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

3 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 9, 2012

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

NCT05289765

Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene

Not ApplicableCompleted

NCT05664503

The Effect of Mobile Health Education on Adaptation to Stoma, Self-efficacy, and Peristomal Lesions

Not ApplicableCompleted

NCT07900711

Suture Choice for Ostomy Creation

Not ApplicableNot Yet Recruiting

current uses two piece tape bordered barrier

has mild to moderate peristomal skin irritation

cares for their stoma independently in the community

at least 3 months post-operative

provides informed consent

You may not qualify if:

has fistula on or near stoma
has been involved in stoma care study in the last 30 days
is pregnant or lactating (determined by interview only)
has existing medical condition that would compromise their participation or follow-up
currently uses convex ostomy products, paste and/or rings
is allergic to test barrier components
is undergoing chemo- or radiotherapy that may affect the interpretation of the results

Contact the study team to confirm eligibility.

Primary Completion

February 2012

Actual (reported)

Study Completion

August 2012

Actual (reported)

Last Updated

March 22, 2016

Results First Posted

March 22, 2016

Record last verified: 2015-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01530087
Data provider: ClinicalTrials.gov
Source updated: 2016-03-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:39 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations