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Recruiting NCT07460323

Study of TRE Seals on Early Post-operative Subjects

No phase Interventional Ostomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: An Ostomy Seal, An Ostomy Ring.
Who it may be relevant to
Registry conditions: Ostomy. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Device An Ostomy Seal
    An absorptive ostomy seal
  • Device An Ostomy Ring
    The Ostomy Ring contains Aloe

Primary outcome measures

  • The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI) [Time frame: From enrollment to the end of treatment at 9 weeks]
Secondary outcome measures (12)
  • Total Ostomy Complication Severity Index (OCSI) score and six stomal complication (non-PSC) domains of the OCSI and associated severity [Time frame: From enrollment to the end of treatment at 9 weeks]
  • Mediation of peristomal skin complications (PSCs) by leakage absorption measured using the leakage item on the Ostomy Complication Severity Index (OCSI) [Time frame: From enrollment to the end of treatment at 9 weeks]
  • Visible moisture/effluent on peristomal skin under the study seal area (OCSI Supplementary Question) [Time frame: From enrollment to the end of treatment at 9 weeks]
  • Seal absorption of moisture/effluent under the study seal area (OCSI Supplementary Question) [Time frame: From enrollment to end of treatment at 9 weeks]
  • Presence of peristomal skin conditions (OCSI Supplementary Question) [Time frame: From enrollment to end of treatment at 9 weeks]
  • Peristomal skin burning severity (OCSI Supplementary Question) [Time frame: From enrollment to end of treatment at 9 weeks]
  • Peristomal skin itching severity (OCSI Supplementary Question) [Time frame: From enrollment to end of treatment at 9 weeks]
  • Time to resolution of peristomal skin complications (PSCs), assessed by the Ostomy Complication Severity Instrument (OCSI) at visits and adverse event (AE) reports between visits [Time frame: From first PSC onset to resolution through end of treatment at 9 weeks]
  • Time to recurrence of peristomal skin complications (PSCs) after resolution, assessed by the OCSI at visits and AE reports between visits [Time frame: From PSC resolution to first recurrence through end of treatment at 9 weeks]
  • Proportion of participants with PSC occurrence, PSC resolution, and PSC recurrence, assessed by the OCSI at visits and AE reports between visits [Time frame: From enrollment to end of treatment at 9 weeks]
  • Patient satisfaction with the study Seal/Ring assessed using the Study-Specific Patient Satisfaction Questionnaire (Likert scale) [Time frame: From enrollment to the end of treatment at 9 weeks]
  • Clinician Satisfaction with the study Seal/Ring assessed using the Study-Specific Clinician Satisfaction Questionnaire (Likert scale) [Time frame: From enrollment to the end of treatment at 9 weeks]

Eligibility criteria

Inclusion criteria

  • 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)
  • Is appropriate to use a barrier seal per the Investigator
  • Able to provide an informed consent for study participation
  • Willing to follow protocol procedures, including participating in study visits, as demonstrated by signing the informed consent

Exclusion criteria

  • 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
  • Has an open draining wound (not including mucocutaneous separation) in the peristomal area at time of enrollment
  • Has a suspected infection in the peristomal area at time of enrollment
  • Is pregnant or lactating at time of enrollment (as determined by interview only)
  • Is unable to speak, read, and understand English.
  • Is currently participating in another clinical study using ostomy products
  • Is currently an employee of Hollister Incorporated or any ostomy manufacturer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United Kingdom · 6 centers
  • North Tees University Hospital — Stockton-on-Tees
  • East Sussex Healthcare NHS Trust: Conquest and Eastbourne Hospitals — Saint Leonards-on-Sea
  • William Harvey Hospital — Ashford
  • Queen Elizabeth The Queen Mother Hospital — Margate
  • East Surrey Hospital — Redhill
  • University Hospital Coventry — Coventry

Identifiers

NCT: NCT07460323 · 6042-OST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗