NCT01534039

A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Independent Nurse Consultants LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Peristomal Skin Complication

Interventions

Type	Name	Description
DEVICE	Sur-Fit Natura	ConvaTec Moldable Skin Barrier for ostomy patients
DEVICE	FormaFlex	Hollister skin barrier for ostomy patients

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-02-16
• Last updated: 2013-09-24

Locations

1 site across 1 country: United States