Investigation of Patient Benefits With a New Supporting Ostomy Product in Patients With a Newly Stoma Formation

Launched by COLOPLAST A/S · Nov 22, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have provide written informed consent.
• • 2. Be at least 18 years of age and have full capacity.
• • 3. Have had their stoma for less than 9 months.
• • 4. Have intact skin on the peristomal area (assessed by investigator)
• • 5. Be able to use one of the five test products (i.e. Ø40, Ø50, Ø60, Ø70, Ø80 mm)
• • 6. Ileo- or colostomists with liquid and/or mushy output (Bristol scale type 5-7)
• • 7. Is willing to refrain from use of paste and protective sheets.
• • 8. Have a smartphone applicable for the HeyloTM app.
• • 9. Have been self-managing stoma appliance for at least 14 days.
• • 10. Are able to follow study procedures for 3 months (assessed by investigator)
• • 11. Are willing to receive their ostomy products through Coloplast Charter for the duration of the study.
• Exclusion Criteria:
• • 1. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
• • 2. Is breastfeeding.
• • 3. Is pregnant based on urine pregnancy test.
• • 4. Enrolled in another current research study or have previously participated in this investigation.
• • 5. Has known hypersensitivity towards any of the products used in the investigation.
• • 6. Is using/have a pacemaker.
• • 7. Has a complicated stoma at baseline (dehiscence/prolapse/hernia)
• • 8. Has limited life expectancy or receive palliative care.
• • 9. Has stage 4 cancer.
• • 10. Having more than one stoma synchronously
• • 11. Having ongoing non-healed abdominal wounds
• • 12. Reoperation / stoma reversal planned during the study period.