A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

Peristomal Skin Complication Clinical Trial

Official title: Phase 4-A Clinical Comparison of a Marketed Moldable Skin Barrier Versus a Marketed Stretch-to-Fit Skin Barrier in Healthy Volunteers

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Peristomal Skin Complication

• NCT number: NCT01534039
• Study type: Interventional
• Source: Independent Nurse Consultants LLC
• Status: Completed
• Phase: Phase 4
• Start date: December 2011
• Completion date: May 2012