A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

Stoma Site Leakage Clinical Trial

Official title:

A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544566
• Other study ID #: CP319
• Status: Completed
• Phase: N/A
• Start date: July 7, 2020
• Est. completion date: August 21, 2020

Study information

• Verified date: April 2021
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 21, 2020
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stoma Site Leakage

Intervention

Device:
• Test product A
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
• Test product B
one new adhesive material which is applied to the baseplate and the subjects peristomal skin
• Comparator
Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin

Locations

Country	Name	City	State
Denmark	Bispebjerg hospital	Copenhagen	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	The measurements were carried out after 7-9 days of treatment with the test tape
Secondary	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.	The measurements were carried out after 7-9 days of treatment with the test tape
Secondary	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.	The evaluation was carried out after 7-9 days of treatment with the test tape
Secondary	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.	The evaluation was carried out after 7-9 days of treatment with the test tape
Secondary	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.	The evaluation was carried out after 7-9 days of treatment with the test tape
Secondary	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).	The evaluation was carried out after 7-9 days of treatment with the test tape
Secondary	Adverse Events	All Adverse Events are captured and documented throughout the study.	27 days