A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

Independent Nurse Consultants LLC

Status and phase

Completed

Phase 4

Conditions

Peristomal Skin Complication

Treatments

Device: FormaFlex

Device: Sur-Fit Natura

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01534039

INC#001

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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