Study of TRE Seals on Early Post-operative Subjects
ConditionOstomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHollister Incorporated
About this trial
This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.
Eligibility criteria
Qualifiers
At least 18 years of age
Has their ostomy surgery and post-operative care in the United Kingdom (UK)
Has a colostomy, ileostomy, or urostomy and no reversal planned during the study evaluation period
Able to have first study product applied at first pouch change after surgery (or up to 4 days post-op)
Disqualifiers
Is over 85 years of age
Has received chemotherapy or radiation in the past 30 days or reports beginning chemotherapy or radiation during the study.
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
Has a fistula in the peristomal area at time of enrollment
Trial design
Treatments tested in this trial
- An Ostomy Seal
- An Ostomy Ring
Treatment groups
107 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov