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Completed

NCT Number: NCT04544566

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

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.

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Key information

Conditions

Stoma Site Leakage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg hospital

Copenhagen, Copenhagen NV, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Test Product A

Device

one new adhesive material which is applied to the baseplate and the subjects peristomal skin

Test product B

Device

one new adhesive material which is applied to the baseplate and the subjects peristomal skin

COMPARATOR

Device

Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. Adverse Events

    Time frame: 27 days

    All Adverse Events are captured and documented throughout the study.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2020
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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