Human Skin Test Model in Colostomists

Colostomy Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918085
• Other study ID #: CP228
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: January 28, 2014
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: January 2014
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Colostomy Stoma

Intervention

Other:
• Hydrocolloid strip
An adhesive strip made of hydrocolloid adhesive
• Strata strip
An adhesive strip made of the Strata adhesive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No