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

NCT02003404 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2016-11-11

Study results available
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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.

Conditions

  • Dermatologic Complications

Interventions

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.

Sponsors & Collaborators

  • Loyola University

    collaborator OTHER

  • Hollister Incorporated

    lead INDUSTRY

Principal Investigators

  • James Swan, MD · Loyola University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02003404 on ClinicalTrials.gov