An Exploratory Study Investigating Human Skin Reaction to Output
An Exploratory Study Investigating Human Skin Reaction to Output
The primary purpose of the study is to investigate the impact that feces mixtures have on the
 peristomal skin when using a standard adhesive.
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).
Inclusion Criteria:

 -  Have given written informed consent

 -  Be at least 18 years of age and have full legal capacity

 -  Have had an ileostomy for more than one year

 -  Have normal to slightly red skin on the area used in the evaluation

 -  Has an ileostomy with a diameter up to (≤) 35 mm

 -  Have a peristomal area accessible for applied patches (assessed by investigator)

 Exclusion Criteria:

 -  Currently receiving or have within the past 2 months received radio- and/or
 chemotherapy

 -  Currently receiving or have within the past month received topical steroid treatment
 in the peristomal skin area or systemic steroid (tablet/injection) treatment

 -  Are pregnant or breastfeeding

 -  Having dermatological problems in the peristomal- or abdominal area (assessed by
 investigator)

 -  Participating in other interventional clinical investigations or have previously
 participated in this investigation