N/A
N=22
Human Skin Test Model in Colostomists
Colostomy Stoma
Bottom Line
View on ClinicalTrials.gov: NCT01918085 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Peel Force — 2.6; 2.1; 4.4; 3.4 Newton
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hydrocolloid strip (Other); Strata strip (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peel Force |
2.6; 2.1; 4.4; 3.4 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01918085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.