NCT02351791

An Exploratory Study Investigating Human Skin Reaction to Output

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.

Detailed description

Six types of patches are tested: Patch 1: Standard adhesive with own feces Patch 2: Standard adhesive with own feces mixture Patch 3: Standard adhesive with simulated feces Patch 4: Standard adhesive with simulated feces mixture Patch 5: Standard adhesive with buffer (control) Patch 6: Standard adhesive with buffer feces mixture (control) Each subject is randomized to one of two arms testing three patches on the peristomal skin (patch 1, 3 and 5 or patch 2, 4 and 6). Furthermore, within each arm an attempt will be made to randomize each of the three patches on the peristomal skin to one of three locations surrounding the stoma (upper left, upper right, lower). On the healthy contralateral abdominal skin the subjects test all six patches. A run in period with 2 subjects (healthy volunteers) was conducted to clarify the length of the test period. They were exposed to 4 patches (patch 3-6) on healthy abdominal skin which was removed at 2 different time slots. Based on the results the test period was established

Conditions

• Ileostomy

Interventions

Type	Name	Description
OTHER	Patch 1	Patch 1:standard adhesive with own feces in sleeve
OTHER	Patch 2	Patch 2:standard adhesive with own feces mixture in sleeve
OTHER	Patch 3	Patch 3: standard adhesive with simulated feces in sleeve
OTHER	Patch 4	Patch 4:standard adhesive with simulated feces mixture in sleeve
OTHER	Patch 5	Patch 5:standard adhesive with buffer in sleeve
OTHER	Patch 6	Patch 6:standard adhesive with buffer mixture in sleeve

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2015-01-30
• Last updated: 2023-10-02
• Results posted: 2023-10-02

Locations

1 site across 1 country: Denmark