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A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

NCT01534039 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-09-24

No results posted yet for this study

Summary

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.

Conditions

  • Peristomal Skin Complication

Interventions

DEVICE

Sur-Fit Natura

ConvaTec Moldable Skin Barrier for ostomy patients

DEVICE

FormaFlex

Hollister skin barrier for ostomy patients

Sponsors & Collaborators

  • ConvaTec Inc.

    collaborator INDUSTRY

  • Independent Nurse Consultants LLC

    lead OTHER

Principal Investigators

  • Ann M Durnal, RN BSN WOCN · Independent Nurse Consultants LLC

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01534039 on ClinicalTrials.gov