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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
12
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
Bispebjerg hospital
Copenhagen, Copenhagen NV, Denmark
Mean Adherent Area Measured by Photo of Used Tape
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.
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
Erythema Measured After Each Treatment Period by Spectrophotometric Method
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.
Time frame: The measurements were carried out after 7-9 days of treatment with the test tape
Erythema Measured After Tape Removal by Photos
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.
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Time frame: The measurements were carried out after 7-9 days of treatment with the test tape
Feeling of Security
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.
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
Adhesion of 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.
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
Comfort
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.
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
Skin Issues in the Area Covered by the Tape
Subjects will be asked if they had any skin-related complications in the area covered by the tape (yes, no).
Time frame: The evaluation was carried out after 7-9 days of treatment with the test tape
Adverse Events
All Adverse Events are captured and documented throughout the study.
Time frame: 27 days