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A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

NCT ID: NCT01534039

Last Updated: 2013-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-05-31

Brief Summary

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A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or urostomy.

Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin protection, wear-time, ease of use, ease of teaching, and comfort.

Detailed Description

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Study to include 60 subjects, three centers, total of 4 weeks, 2 weeks in each product. Subjects recruited from a population of persons who have had an existing fecal or urinary stoma for a duration of at least three months. There is no restriction on primary diagnosis for ostomy surgery. Subjects must be of legal consenting age, must currently be managing their own stoma with a two piece pouching system, either a pre-cut, cut to fit, moldable or stretch-to-fit, any manufacturer. Subjects may not require convexity and be willing to not to use any accessory products during the study.

Conditions

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Peristomal Skin Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Sur-Fit Natura/FormaFlex

Subject will be on Surfit Moldable for 2 weeks then crossover to Formaflex

Group Type ACTIVE_COMPARATOR

Sur-Fit Natura

Intervention Type DEVICE

ConvaTec Moldable Skin Barrier for ostomy patients

FormaFlex/Sur-Fit Natura

Subject will be on Formaflex for 2 weeks then crossover to Surfit Moldable

Group Type ACTIVE_COMPARATOR

FormaFlex

Intervention Type DEVICE

Hollister skin barrier for ostomy patients

Interventions

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Sur-Fit Natura

ConvaTec Moldable Skin Barrier for ostomy patients

Intervention Type DEVICE

FormaFlex

Hollister skin barrier for ostomy patients

Intervention Type DEVICE

Other Intervention Names

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ConvaTec Moldable Skin Barrier Hollister FormaFlex

Eligibility Criteria

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Inclusion Criteria

* Existing fecal or urinary ostomy for at least three months,consenting age, able to perform independent ostomy care, willing to not use accessory products, currently wearing a 2 piece marketed product.
* Able to participate for four weeks.

Exclusion Criteria

* Needing convexity.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ConvaTec Inc.

INDUSTRY

Sponsor Role collaborator

Independent Nurse Consultants LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann M Durnal, RN BSN WOCN

Role: PRINCIPAL_INVESTIGATOR

Independent Nurse Consultants LLC

Locations

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Independent Nurse Consultants LLC

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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INC#001

Identifier Type: -

Identifier Source: org_study_id