Human Skin Test Model in Colostomists

Study Overview
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Brief Summary
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The aim of the study is to investigate the correlation in peel force when peeling off a standard hydrocolloid adhesive strip and standard strata adhesive strip from peristomal skin compared to pre-stripped healthy abdominal skin in colostomists.

Official Title
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Open, Prospective, Single Centre, Randomized, Controlled, Cross-over. Clinical Study Investigating the Correlation in Peel Force of Standard Hydrocolloid Adhesive and a Standard Strata Adhesive From Peristomal Skin and Pre-stripped Abdominal Skin in Colostomists

Conditions
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Colostomy Stoma

Intervention / Treatment
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* Other: Hydrocolloid strip
* Other: Strata strip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have given written informed consent. Be in the age of 45 to 75 years of age both extremes included. Have had a colostomy for at least 1 year. Has a colostomy with a diameter up to (≤) 40 mm. Have mental capacity to understand the study guidelines and questionnaires. Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation. Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance. Have a BMI between 20-30 kg/m2. Are willing to comply with investigation procedures. Exclusion Criteria: Currently suffering from peristomal skin problems (i.e. bleeding or broken skin). Received radio- and/or chemotherapy within the last two months. Currently using or have within the last 3 weeks used topical steroid products or other skin prep products. on peristomal skin (injections and oral treatment are accepted). Have dermatological problems. Participating in other clinical studies or have previously participated in this test. Be a daily user of a convex base-plate. Are pregnant or breastfeeding. Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Peristomal skin<br>The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin | Other: Hydrocolloid strip<br>* An adhesive strip made of hydrocolloid adhesive<br>Other: Strata strip<br>* An adhesive strip made of the Strata adhesive<br>|
| Other: Pre-stripped abdominal skin<br>The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin | Other: Hydrocolloid strip<br>* An adhesive strip made of hydrocolloid adhesive<br>Other: Strata strip<br>* An adhesive strip made of the Strata adhesive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peel Force | The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees. The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects. | 1 hour |