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

NCT04544566 | Completed Results

• 1 other identifier: CP319
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stoma Site Leakage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Erythema Measured After Each Treatment Period by Spectrophotometric Method

  The measurements were carried out after 7-9 days of treatment with the test tape

• Erythema Measured After Tape Removal by Photos

  The measurements were carried out after 7-9 days of treatment with the test tape

• Feeling of Security

  The evaluation was carried out after 7-9 days of treatment with the test tape

• Adhesion of Tape

  The evaluation was carried out after 7-9 days of treatment with the test tape

• Comfort

  The evaluation was carried out after 7-9 days of treatment with the test tape

Study Arms (3)

Test product A new adhesive material

EXPERIMENTAL

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.

Device: Test product A; Device: Test product B; Device: Comparator

Test product B new adhesion material

EXPERIMENTAL

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.

Device: Test product A; Device: Test product B; Device: Comparator

Comparator

ACTIVE 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.

Device: Test product A; Device: Test product B; Device: Comparator

Interventions

Test product A DEVICE

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

Comparator; Test product A new adhesive material; Test product B new adhesion material

Test product B DEVICE

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

Comparator; Test product A new adhesive material; Test product B new adhesion material

Comparator DEVICE

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

Comparator; Test product A new adhesive material; Test product B new adhesion material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Bispebjerg hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

Limitations and Caveats

One subject missed completing questionnaire related to secondary end points for Test Tape A and Comparator Tape and one subject was included in the study despite treatment with steroid cream of pyoderma ulcers. The treatment was close to being completed and was assessed by investigator as a deviation that had no impact on the rights, safety and well-being of the subject or that could impact the scientific outcome of the investigation.

Results Point of Contact

• Title: Head of Scientific Affairs
• Organization: Coloplast A/S

clinicaltrialsgovSA@coloplast.com

+45 4911 1111

Study Officials

• Tonny Karlsmark, MD

  Bispebjerg hospital, Dermato-Venerologisk afdeling.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: September 10, 2020
• Study Start: July 7, 2020
• Primary Completion: August 21, 2020
• Study Completion: August 21, 2020
• Last Updated: May 6, 2021
• Results First Posted: May 6, 2021

Record last verified: 2021-04

Locations

DK (1)