CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Control Abdominal Skin +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02003404
NCT02003404N/ACompleted
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Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin

Hollister Incorporated·observational·Posted Dec 6, 2013·Updated Nov 11, 2016

In Brief

An observational study evaluating Control Abdominal Skin and Peristomal Abdominal Skin for Dermatologic Complications. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDermatologic Complications
CountriesUnited States
CollaboratorsLoyola University

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 6, 2013
Enrollment StartNov 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.6 years ago

Interventions

Control Abdominal Skindevice

Three barrier materials will be peeled from abdominal skin after a set period at a set rate.

Peristomal Abdominal Skindevice

Three barrier materials will be peeled from abdominal skin after a set period at a set rate.