- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04544566
A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
April 13, 2021 updated by: Coloplast A/S
An investigation of non-CE marked stoma tape products.
This investigation is a randomised, open-label, comparative, cross-over study, with three test periods.
In total, 12 subjects will be included and randomised.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The test products are non-CE marked stoma tape products.
This investigation is a randomised, open-label, comparative, cross-over study, with three test periods.
In total, 12 subjects will be included and randomised.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Copenhagen NV
-
Copenhagen, Copenhagen NV, Denmark, 2400
- Bispebjerg Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Has given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than ½ year
- Have intact skin on the area used in the study (Assessed by investigator, see Appendix 1).
- Willing to change baseplate every second day or less frequent
- Willing to avoid using Concave baseplate during the study.
- Willing to avoid the use of barrier creams or similar that affect the skin/adhesive interface under the tape.
Exclusion Criteria:
- Currently receiving or have within the past 2 months received radio-and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet(injection) treatment
- Is pregnant or breastfeeding
- Having dermatological problems in the peristomal area (assessed by investigator)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Test product A new adhesive material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes.
At the same time, the tape should be easy to remove without affecting the skin.
|
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
EXPERIMENTAL: Test product B new adhesion material
The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes.
At the same time, the tape should be easy to remove without affecting the skin.
|
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
ACTIVE_COMPARATOR: Comparator
The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation.
|
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Adherent Area Measured by Photo of Used Tape
Time Frame: Tapestrips per test product were removed from the baseplate at each product change and saved for the next site visit every 7-9 days for evaluation
|
The adherent area (cm2) measured per baseplate change after use shows how effectively the ostomy tape adheres to the skin.
After removal of the ostomy tape, a photo of the tape was taken.
The adherent area was measured from the photo and an image analysing program.
|
Tapestrips per test product were removed from the baseplate at each product change and saved for the next site visit every 7-9 days for evaluation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythema Measured After Each Treatment Period by Spectrophotometric Method
Time Frame: The measurements were carried out after 7-9 days of treatment with the test tape
|
A change in the surface skin colour is known to be related to a change in the blood flow.
This can be measured non-invasively with a spectrophotometric instrument (Derma-spectrophotometer, Cortex Technology A/S, Hadsund) where redness of the skin is measured.
The measurement of erythema is based on an active color detecting chip.
Illumination is provided by two high intensity white LEDs.
The spectrophotometer accommodates the color sensor, filters, optics and light source.
Light is provided by two high intensity with LEDs and a unique feature is the guiding light, which illuminates the target during the positioning of the device.
The LEDs illuminates the target area and the skin color measurement is performed.
The measurements performed with the spectrophotometric instrument do not have units.
But the measures are used for the estimation of the level of the redness (hemoglobin) in the skin.
The higher the value, the more pigment in the skin.
|
The measurements were carried out after 7-9 days of treatment with the test tape
|
Erythema Measured After Tape Removal by Photos
Time Frame: The measurements were carried out after 7-9 days of treatment with the test tape
|
A change in the surface skin colour is known to be related to a change in the blood flow.
This can be measured non-invasively with a spectrophotometric instrument (Derma-spectrophotometer, Cortex Technology A/S, Hadsund) where both the redness and the colour of the skin are measured.
Furthermore, visual assessments of photos have been used in several exploratory clinical investigations by Coloplast A/S to explore how adhesives affect the skin.
The visual assessment is conducted by trained personnel and is a valuable tool for assessing newly developed adhesives and their impact on skin in the early development phases.
|
The measurements were carried out after 7-9 days of treatment with the test tape
|
Feeling of Security
Time Frame: The evaluation was carried out after 7-9 days of treatment with the test tape
|
Subjects will be asked how they rate feeling of security ("How was the feeling of security?) on a five point scale, when wearing the tape; 1. Very Poor, 2. Poor, 3. Acceptable, 4. Good, 5. Very Good.
|
The evaluation was carried out after 7-9 days of treatment with the test tape
|
Adhesion of Tape
Time Frame: The evaluation was carried out after 7-9 days of treatment with the test tape
|
Subjects will be asked how they perceive the immediate adhesion to the skin ("how was the immediate adhesion to the skin?) and rate adhesion on a five-point scale: 1. Very poor, 2. Poor, 3. Acceptable, 4. Good, 5. Very good.
|
The evaluation was carried out after 7-9 days of treatment with the test tape
|
Comfort
Time Frame: The evaluation was carried out after 7-9 days of treatment with the test tape
|
Subjects will be asked how they perceived the comfort of the tape ("How comfortable was the tape to wear?") and rate comfort on a 5-pont scale; 1. very discomfortable, 2. Discomfortable, 3. Acceptable, 4. Comfortable, 5. Very comfortable.
|
The evaluation was carried out after 7-9 days of treatment with the test tape
|
Skin Issues in the Area Covered by the Tape
Time Frame: The evaluation was carried out after 7-9 days of treatment with the test tape
|
Subjects will be asked if they had any skin-related complications in the area covered by the tape (yes, no).
|
The evaluation was carried out after 7-9 days of treatment with the test tape
|
Adverse Events
Time Frame: 27 days
|
All Adverse Events are captured and documented throughout the study.
|
27 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tonny Karlsmark, MD, Bispebjerg hospital, Dermato-Venerologisk afdeling.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 7, 2020
Primary Completion (ACTUAL)
August 21, 2020
Study Completion (ACTUAL)
August 21, 2020
Study Registration Dates
First Submitted
June 26, 2020
First Submitted That Met QC Criteria
September 3, 2020
First Posted (ACTUAL)
September 10, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 6, 2021
Last Update Submitted That Met QC Criteria
April 13, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- CP319
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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