NCT02003404

Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Hollister Incorporated · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This purpose of this study is to look at three commercially available ostomy barriers on peristomal (around the stoma) skin. Repeated barrier application and removal over years causes changes to the skin that the investigators wish to investigate. The primary objective is to measure peel force on normal skin and peel force on peristomal skin, with the intent of determining if differences occur. The study hypotheses is that no differences exist.

Detailed description

This is a single center, non-invasive exploratory study utilizing a sample of convenience. This study compares three commercially available barrier materials on peristomal skin and normal abdominal skin.

Conditions

• Dermatologic Complications

Interventions

Type	Name	Description
DEVICE	Control Abdominal Skin	Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
DEVICE	Peristomal Abdominal Skin	Three barrier materials will be peeled from abdominal skin after a set period at a set rate.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-12-06
• Last updated: 2016-11-11
• Results posted: 2015-10-19

Locations

1 site across 1 country: United States