Colostomy Clinical Trial
Official title:
Cross-over, Open Label Study Evaluating a New Ostomy Appliance With Regard to Leakage, Handling and Comfort
The objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to SenSura.
Peristomal skin problems are reported to have a negative impact on the quality of life of
people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent
in contact with the peristomal skin (leakage) appears to predispose patients to peristomal
skin problems.
To protect the skin against effluent, the appliance used for collection of stoma effluent
should completely cover the peristomal skin close to the stoma. Coloplast has developed a
new ostomy appliance to improve the feeling of security and increase comfort by the
appliance characteristics.
The objective of this investigation is to evaluate leakage, handling and comfort of a new
ostomy appliance compared to SenSura.
The study is a randomised controlled cross-over intervention study, where all study
participants will test two test products (new ostomy appliance and SenSura). Each test
period will last 10 ± 2 days and the subjects will follow their usual wear and change
pattern. The participants will visit the study investigator at study start and at
cross-over. Evaluation of the test products will occur via questionnaires the subjects fill
in at home.
50 healthy subjects with a colostomy will be included in the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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