CompletedNot Applicable

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

United States17 participantsStarted 2013-11

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Colostomy, Ileostomy, or Urostomy patients at least 6 months post-surgery * Males or females, age 18 to 80 years old at the time of enrollment * Body Mass Index (BMI) between 18 and 50 * Willing to have two approximately 5" x 5" areas of the abdomen trimmed with a surgical clipper -- one in a ring around the stoma, and one on the opposite side * Willing to remain within the testing room for the duration of the study * Willing to allow a third person in the room as a witness for the duration of the study * Able to position oneself onto and off of the examining table without the assistance of the Investigator * Willing to refrain from vigorous exercise for the duration of the study * Willing to not take any anti-inflammatory medications (except for Tylenol/acetaminophen) starting 48 hours prior to the study and for the duration of the study * Willing to bring an extra barrier and replace their barrier worn during the study. * Willing to follow the protocol as demonstrated by signing the Informed Consent Form * In the opinion of the Investigator or qualified site personnel is qualified to participate Exclusion Criteria: * Clinically significant diseases, which may or may not be confined to the testing site, that may contraindicate participation; including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer * Use of topical drugs on the application site within 1 month. * Use of lotions, creams, powders or oils on the application sit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Skin Barrier Peel Force

Timeframe: 4 hours

Trial details

NCT IDNCT02003404

SponsorHollister Incorporated

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-02

Results submitted2014-09-15

View on ClinicalTrials.gov More Dermatologic Complications trials