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NCT02003404 · ClinicalTrials.gov registry record
Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin
A clinical trial, sponsored by Hollister Incorporated.
- Completed
- Registry status
- 17
- Enrollment target
NCT02003404: Completed study, sponsored by Hollister Incorporated.
NCT02003404 is a clinical trial that has completed, run by Hollister Incorporated. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02003404 has completed, sponsored by Hollister Incorporated.
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.
Interventions
- DEVICE Control Abdominal Skin
- DEVICE Peristomal Abdominal Skin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-02 |
What the finished NCT02003404 record still lists
NCT02003404 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Control Abdominal Skin is the first listed.
NCT02003404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02003404 about?
NCT02003404 is a clinical study titled "Preliminary Study of Peel Force and Discomfort of Removal of Adhesive Barriers in Normal and Peristomal Skin". 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 no...
What is the current status of trial NCT02003404?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2013-11. Estimated completion is 2014-02.
What interventions are being tested in trial NCT02003404?
The interventions under investigation include: Control Abdominal Skin (DEVICE), Peristomal Abdominal Skin (DEVICE).
Who is sponsoring clinical trial NCT02003404?
This trial is sponsored by Hollister Incorporated, which has 11 total clinical trials registered on ClinicalTrials.gov.
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