A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peristomal Skin Complication

Intervention / Treatment
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* Device: Sur-Fit Natura
* Device: FormaFlex


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sur-Fit Natura/FormaFlex<br>Subject will be on Surfit Moldable for 2 weeks then crossover to Formaflex | Device: Sur-Fit Natura<br>* ConvaTec Moldable Skin Barrier for ostomy patients<br>* Other names: ConvaTec Moldable Skin Barrier;|
| Active Comparator: FormaFlex/Sur-Fit Natura<br>Subject will be on Formaflex for 2 weeks then crossover to Surfit Moldable | Device: FormaFlex<br>* Hollister skin barrier for ostomy patients<br>* Other names: Hollister FormaFlex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to maintain secure (snug) fit around stoma | Subject assessment of barrier fit based on questionnaire at each skin barrier change up to 2 weeks Barrier gap assessment performed by nurse at 2 weeks Barrier gap assessment performed by subject at each skin barrier change up to 2 weeks | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Protection | SACS assessment by patient at each barrier change up to 2 weeks SACS assessment by nurse at 2 weeks | Two weeks | 
| Wear Time | 1. Time of barrier change recorded | Two weeks | 
| Ease of use | 1. Assessment by subject response to questionnaire | Two weeks | 
| Ease of teaching | 1. Assessment by nurse of ability to teach subject to use barrier | Two weeks | 
| Comfort | 1. Subject assessment of comfort of barrier at each change | Two weeks |