CompletedPhase 4

A Clinical Comparison of Two Marketed Skin Barriers on Healthy Volunteers

United States60 participantsStarted 2011-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Ability to maintain secure (snug) fit around stoma

Timeframe: Two weeks

Trial details

NCT IDNCT01534039

SponsorIndependent Nurse Consultants LLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-05

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