An interventional study of Buffer and Own output in Ileostomy, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-20.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Basic science
The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.
Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.
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This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions: Buffer Own output Simulated output (digestive enzymes) All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.
Other: Buffer · Other: Own output · Other: simulated output
The sleeve contains phosphate buffered saline buffer
The sleeve contains the subject own ileal effluent
The sleeve contains simulated output
Remaining adhesive area of adhesive
The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area.
Time frame: 30 hours
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Coloplast A/S