An Exploratory Study Investigating Human Skin Reaction to Output

Coloplast

Status: Completed

Conditions: Ileostomy

Treatments: Other: Patch 6; Other: Patch 5; Other: Patch 3; Other: Patch 4; Other: Patch 2; Other: Patch 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02351791

CP254

Details and patient eligibility

About

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

Full 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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Patch 1, 3 and 5

Experimental group

Description:

Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.

Treatment:

Other: Patch 5

Other: Patch 2

Other: Patch 4

Other: Patch 3

Other: Patch 1

Other: Patch 6

Patch 2, 4 and 6

Experimental group

Description:

Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive.

Treatment:

Other: Patch 5

Other: Patch 2

Other: Patch 4

Other: Patch 3

Other: Patch 1

Other: Patch 6