Study of TRE Seals on Early Post-operative Subjects

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ostomy
• Intervention / Treatment: Device: An Ostomy Seal; Device: An Ostomy Ring

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: An Ostomy Seal	Device: An Ostomy Seal; An absorptive ostomy seal
Active Comparator: An Ostomy Ring	Device: An Ostomy Ring; The Ostomy Ring contains Aloe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI)	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.	From enrollment to the end of treatment at 9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Ostomy Complication Severity Index (OCSI) score and six stomal complication (non-PSC) domains of the OCSI and associated severity	Each of the OCSI items are scored on a scale of 0-3, with 0 indicating absence of the condition and 3 indicating the condition is severe.	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)	The leakage item on the OCSI has a scale of 0 (no leakage) to 3 (leakage approximately 1-2 times per day)	From enrollment to the end of treatment at 9 weeks
Visible moisture/effluent on peristomal skin under the study seal area (OCSI Supplementary Question)	Assessed only if leakage is reported in the OCSI tool (conditional). Responses: Great amount / Slight amount / None (ordinal categorical).	From enrollment to the end of treatment at 9 weeks
Seal absorption of moisture/effluent under the study seal area (OCSI Supplementary Question)	Participant response to whether the study seal absorbed moisture/effluent from around the stoma/peristomal skin under the seal. Responses: Yes / Somewhat / No, not at all (ordinal categorical).	From enrollment to end of treatment at 9 weeks
Presence of peristomal skin conditions (OCSI Supplementary Question)	Checklist of skin conditions present: burning, itching, maceration, fungal rash, folliculitis, granuloma, mechanical trauma, product sensitivity/allergy, pyoderma gangrenosum, other, none.	From enrollment to end of treatment at 9 weeks
Peristomal skin burning severity (OCSI Supplementary Question)	Rated on a numeric scale from 0 (absent) to 10 (worst burning imaginable). Assessed only if burning is reported (conditional logic from Q25). Higher scores indicate worse burning.	From enrollment to end of treatment at 9 weeks
Peristomal skin itching severity (OCSI Supplementary Question)	Rated on a numeric scale from 0 (absent) to 10 (worst itching imaginable). Assessed only if itching is reported (conditional logic from Q25). Higher scores indicate worse itching.	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	Unit of Measure: days	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	Unit of Measure: days	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	Unit of Measure: percent (%)	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)	Rated on a 5-point Likert scale from 1 (Very Satisfied) to 5 (Very dissatisfied)	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)	Rated on a 5-point Likert scale from 1 (Very Satisfied) to 5 (Very dissatisfied)	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	Single study-specific question assessing whether instructional resources (e.g., IFU, online guides) enabled correct use of the seal/ring; responses: Yes / No / Did not use instructional resources. Results will be reported as the proportion of participants in each response category.	From enrollment to the end of treatment at 9 weeks
Seal swelling/expansion incidence, assessed by Study-Specific Swell/Expand Question	Participant response comparing seal size at application versus at barrier change. Responses: No, seal did not swell/expand / Yes, seal swelled/expanded.	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	Participant response regarding whether swelling/expansion provided a better, more secure fit against leakage. Responses: No, not at all / Yes, somewhat / Yes, definitely (ordinal categorical).	From enrollment to end of treatment at 9 weeks
Perceived moisture-wicking effect, assessed by the Study-Specific Moisture-Wicking Question (3-point scale)	Single study-specific question assessing perceived moisture-wicking away from peristomal skin. Responses: No, not at all / Yes, somewhat / Yes, definitely.	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)	Rated on a 5-point Likert scale from 1 (Strongly agree) to 5 (Strongly disagree)	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	Unit of measure: mean/median number used per participant (counts)	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	Unit of measure: hours or days of wear time per application (time)	From enrollment to end of treatment at 9 weeks
Peristomal skin-related unplanned healthcare visits, assessed by Study-Specific Healthcare Utilization Question	Unit of measure: number of visits per participant; optionally proportion with ≥1 visit (counts/%)	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	Unit of measure: currency (e.g., dollars)	From enrollment to end of treatment at 9 weeks

Collaborators and Investigators

• Sponsor: Hollister Incorporated

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 6042-OST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No