Human Skin Test Model in Colostomists

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

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.

Study Overview

• Status: Completed
• Conditions: Colostomy Stoma
• Intervention / Treatment: Other: Hydrocolloid strip; Other: Strata strip

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Tonny Karlsmark, MD, Bispebjerg Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (ESTIMATE): August 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 12, 2014
• Last Update Submitted That Met QC Criteria: January 28, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: CP228