Human Skin Test Model 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.

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Key information

Conditions

Colostomy Stoma

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Hydrocolloid strip

Other

An adhesive strip made of hydrocolloid adhesive

Strata strip

Other

An adhesive strip made of the Strata adhesive

Primary outcomes

Peel Force

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Aug 7, 2013
Registry last updated: Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed