A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
Twelve subjects are to be recruited into this 10 day single centre study to assess primarily safety in terms of adverse events and condition of the skin surrounding the stoma and condition of the stoma. Performance will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
11
A one piece closed pouch for the collection of stool from a colostomy stoma
Independent Nurse Consultants LLC
Tucson, Arizona, United States
Safety
Safety in relation to type and number of adverse events, condition of the skin surrounding the colostomy stoma and condition of the stoma
Time frame: 10 days - duration of study period
Performance/Efficacy
Performance/Efficacy of the pouch to stay in place and collect stool from the stoma. Ease of use, security will be assessed
Time frame: 10 days duration of study period
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