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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
60
ConvaTec Moldable Skin Barrier for ostomy patients
Hollister skin barrier for ostomy patients
Independent Nurse Consultants LLC
Tucson, Arizona, United States
Ability to maintain secure (snug) fit around stoma
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
Time frame: Two weeks
Skin Protection
1. SACS assessment by patient at each barrier change up to 2 weeks 2. SACS assessment by nurse at 2 weeks
Time frame: Two weeks
Wear Time
1\. Time of barrier change recorded
Time frame: Two weeks
Ease of use
1\. Assessment by subject response to questionnaire
Time frame: Two weeks
Ease of teaching
1\. Assessment by nurse of ability to teach subject to use barrier
Time frame: Two weeks
Comfort
1\. Subject assessment of comfort of barrier at each change
Time frame: Two weeks
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