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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dermatologic Complications

Intervention / Treatment
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* Device: Control Abdominal Skin
* Device: Peristomal Abdominal Skin


Participation Criteria
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Eligibility Criteria
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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 site in the 24 hours prior to application Pregnancy, lactation or planning a pregnancy as determined by interview only Other medical conditions, for example uncontrolled diabetes, which in the Investigator's judgment, makes the subject ineligible or places the subject at undue risk Participation in any clinical test either using the abdomen as a test site or using systemic therapy within the previous thirty days Damaged skin or other skin conditions in or near test sites which includes sunburn, scars, numerous moles or other disfiguration of the test site Significant adipose tissue at the test site that would preclude adequate adhesion of the study devices Known allergy to any of the test materials

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Abdominal Skin<br>Apply SoftFlex (standard wear commercial skin barrier), FlexWear (standard wear commercial skin barrier), and FlexTend (extended wear commercial skin barrier), material to non-peristomal abdominal skin. | Device: Control Abdominal Skin<br>* Three barrier materials will be peeled from abdominal skin after a set period at a set rate.<br>* Other names: FlexTend;|
| Peristomal Abdominal Skin<br>Apply SoftFlex, FlexWear and FlexTend barrier material to peristomal abdominal skin. | Device: Peristomal Abdominal Skin<br>* Three barrier materials will be peeled from abdominal skin after a set period at a set rate.<br>* Other names: FlexTend;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Barrier Peel Force | 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. | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ostomy appliance