Peristomal Skin Complication
Conditions
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.
Interventions
DEVICESur-Fit Natura
ConvaTec Moldable Skin Barrier for ostomy patients
DEVICEFormaFlex
Hollister skin barrier for ostomy patients
Sponsors
ConvaTec Inc.
Independent Nurse Consultants LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed