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โ† Trials
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Study of TRE Seals on Early Post-operative Subjects

RecruitingNAAges 18 Years - 85 YearsAllHollister Incorporated
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In plain words

What the trial is, and whether it could suit you

This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. At least 18 years of age 2. Has their ostomy surgery and post-operative care in the United Kingdom (UK) 3. Has a colostomy, ileostomy, or urostomy and no reversal planned during the study evaluation period 4. Able to have first study product applied at first pouch change after surgery (or up to 4 days post-op) 5. Is appropriate to use a barrier seal per the Investigator 6. Able to provide an informed consent for study participation 7. Willing to follow protocol procedures, including participating in study visits, as demonstrated by signing the informed consent Exclusion Criteria: 1. Is over 85 years of age 2. Has received chemotherapy or radiation in the past 30 days or reports beginning chemotherapy or radiation during the study. 3. A score of 1, 2, or 3 for any of the three OCSI Tool PSC-related domains (i.e., peristomal irritant dermatitis, peristomal bleeding, and hyperplasia) at time of enrollment 4. Has a fistula in the peristomal area at time of enrollment 5. Has an open draining wound (not including mucocutaneous separation) in the peristomal area at time of enrollment 6. Has a suspected infection in the peristomal area at time of enrollment 7. Is pregnant or lactating at time of enrollment (as determined by interview only) 8. Is unable to speak, read, and understand English. 9. Is currently participating in another clinical study using ostomy products 10. Is currently an employee of Hollister Incorporated or any ostomy manufacturer
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What it tests

  • An Ostomy Seal
  • An Ostomy Ring
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Where

6 sites
North Tees University Hospital
Stockton-on-Tees, United Kingdom
East Sussex Healthcare NHS Trust: Conquest and Eastbourne Hospitals
Saint Leonards-on-Sea, United Kingdom
William Harvey Hospital
Ashford, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, United Kingdom
East Surrey Hospital
Redhill, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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