Human Skin Test Model in Colostomists

Not Applicable

Completed

• Conditions: Colostomy Stoma
• Interventions: Other: Hydrocolloid strip; Other: Strata strip

• Registration Number: NCT01918085
• Lead Sponsor: Coloplast A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-06
• Study First Posted: 2013-08-07
• Results First Submitted: 2013-11-21
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-28
• Last Update Submitted: 2014-01-28
• Results First Posted: 2014-03-12
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Have given written informed consent.
2. Be in the age of 45 to 75 years of age both extremes included.
3. Have had a colostomy for at least 1 year.
4. Has a colostomy with a diameter up to (≤) 40 mm.
5. Have mental capacity to understand the study guidelines and questionnaires.
6. Be assessed by the investigator as having a peristomal and abdominal skin condition justifying entry into the investigation.
7. Are colostomists currently using a 1-piece and 2-piece flat ostomy appliance.
8. Have a BMI between 20-30 kg/m2.
9. Are willing to comply with investigation procedures.

Exclusion Criteria

1. Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).

2. Received radio- and/or chemotherapy within the last two months.

3. 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).

4. Have dermatological problems.

5. Participating in other clinical studies or have previously participated in this test.

6. Be a daily user of a convex base-plate.

7. Are pregnant or breastfeeding.

8. Systemic elements that could affect skin histology (e.g. liver, kidney or immunological diseases).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Peristomal skin	Hydrocolloid strip	The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin
Peristomal skin	Strata strip	The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin
Pre-stripped abdominal skin	Hydrocolloid strip	The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin
Pre-stripped abdominal skin	Strata strip	The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin

Primary Outcome Measures

Name	Time	Method
Peel Force	1 hour	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.