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Clinical Trials/NCT07460323
NCT07460323RecruitingNot Applicable

Study of TRE Seals on Early Post-operative Subjects

Hollister Incorporated6 sites in 1 country107 target enrollmentStarted: June 30, 2026Last updated:
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Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
107
Locations
6
Primary Endpoint
The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

An Ostomy Seal

Experimental

Intervention: An Ostomy Seal (Device)

An Ostomy Ring

Active Comparator

Intervention: An Ostomy Ring (Device)

Outcomes

Primary Outcomes

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

The three PSC-related questions on the Ostomy Complication Severity Index (OCSI) are related to peristomal irritant dermatitis, peristomal bleeding, and hyperplasia. Each of these three items is rated on a scale of 0-3, with 0 indicating absence of the condition, and 3 indicating the condition is severe.

Secondary Outcomes

  • Total Ostomy Complication Severity Index (OCSI) score and six stomal complication (non-PSC) domains of the OCSI and associated severity(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)(From enrollment to the end of treatment at 9 weeks)
  • Visible moisture/effluent on peristomal skin under the study seal area (OCSI Supplementary Question)(From enrollment to the end of treatment at 9 weeks)
  • Seal absorption of moisture/effluent under the study seal area (OCSI Supplementary Question)(From enrollment to end of treatment at 9 weeks)
  • Presence of peristomal skin conditions (OCSI Supplementary Question)(From enrollment to end of treatment at 9 weeks)
  • Peristomal skin burning severity (OCSI Supplementary Question)(From enrollment to end of treatment at 9 weeks)
  • Peristomal skin itching severity (OCSI Supplementary Question)(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(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(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(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)(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)(From enrollment to the end of treatment at 9 weeks)
  • Ability to correctly use the seal/ring with available instructional resources, assessed by the Study-Specific Instructional Resources Question(From enrollment to the end of treatment at 9 weeks)
  • Seal swelling/expansion incidence, assessed by Study-Specific Swell/Expand Question(From enrollment to the end of treatment at 9 weeks)
  • Effectiveness of seal swelling/expansion for secure fit against leakage, assessed by Study-Specific Swell/Expand Question(From enrollment to end of treatment at 9 weeks)
  • Perceived moisture-wicking effect, assessed by the Study-Specific Moisture-Wicking Question (3-point scale)(From enrollment to the end of treatment at 9 weeks)
  • Clinician agreement with the study Seal/Ring performance assessed using the Study-Specific Clinician Agreement Questionnaire (Likert scale)(From enrollment to the end of treatment at 9 weeks)
  • Quantity of seals/rings, barriers, and accessories used, assessed by Study-Specific Resource Utilization Log(From enrollment to the end of treatment at 9 weeks)
  • Wear/use time (longevity) of seals/rings and barriers, assessed by Study-Specific Resource Utilization Log(From enrollment to end of treatment at 9 weeks)
  • Peristomal skin-related unplanned healthcare visits, assessed by Study-Specific Healthcare Utilization Question(From enrollment to end of treatment at 9 weeks)
  • Total ostomy seal/ring costs, derived from quantities recorded in the Resource and Healthcare Utilization Logs(From enrollment to end of treatment at 9 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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