A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

Phase 4

Completed

• Conditions: Peristomal Skin Complication
• Interventions: Device: Sur-Fit Natura; Device: FormaFlex

• Registration Number: NCT01534039
• Lead Sponsor: Independent Nurse Consultants LLC

Brief 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-16
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sur-Fit Natura/FormaFlex	Sur-Fit Natura	Subject will be on Surfit Moldable for 2 weeks then crossover to Formaflex
FormaFlex/Sur-Fit Natura	FormaFlex	Subject will be on Formaflex for 2 weeks then crossover to Surfit Moldable

Primary Outcome Measures

Name	Time	Method
Ability to maintain secure (snug) fit around stoma	Two weeks	1. Subject assessment of barrier fit based on questionnaire at each skin barrier change up to 2 weeks; 2. Barrier gap assessment performed by nurse at 2 weeks; 3. Barrier gap assessment performed by subject at each skin barrier change up to 2 weeks

Secondary Outcome Measures

Name	Time	Method
Ease of use	Two weeks	1. Assessment by subject response to questionnaire
Ease of teaching	Two weeks	1. Assessment by nurse of ability to teach subject to use barrier
Comfort	Two weeks	1. Subject assessment of comfort of barrier at each change
Skin Protection	Two weeks	1. SACS assessment by patient at each barrier change up to 2 weeks; 2. SACS assessment by nurse at 2 weeks
Wear Time	Two weeks	1. Time of barrier change recorded

Trial Locations

Locations (1)

Independent Nurse Consultants LLC; 🇺🇸 Tucson, Arizona, United States