Human Skin Test Model in Colostomists

Coloplast

Status

Completed

Conditions

Colostomy Stoma

Treatments

Other: Strata strip

Other: Hydrocolloid strip

Study type

Interventional

Funder types

Industry

Identifiers

NCT01918085

CP228

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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).