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NCT Number: NCT07460323

Study of TRE Seals on Early Post-operative Subjects

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

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Key information

Conditions

Ostomy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Tees University Hospital, Stockton-on-Tees, County Durham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

An Ostomy Seal

Device

An absorptive ostomy seal

An Ostomy Ring

Device

The Ostomy Ring contains Aloe

Primary outcomes

  1. 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

  1. 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

    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.

  2. 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

    The leakage item on the OCSI has a scale of 0 (no leakage) to 3 (leakage approximately 1-2 times per day)

  3. 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

    Assessed only if leakage is reported in the OCSI tool (conditional). Responses: Great amount / Slight amount / None (ordinal categorical).

  4. Seal absorption of moisture/effluent under the study seal area (OCSI Supplementary Question)

    Time frame: From enrollment to end of treatment at 9 weeks

    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).

  5. Presence of peristomal skin conditions (OCSI Supplementary Question)

    Time frame: From enrollment to end of treatment at 9 weeks

    Checklist of skin conditions present: burning, itching, maceration, fungal rash, folliculitis, granuloma, mechanical trauma, product sensitivity/allergy, pyoderma gangrenosum, other, none.

  6. Peristomal skin burning severity (OCSI Supplementary Question)

    Time frame: From enrollment to end of treatment at 9 weeks

    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.

  7. Peristomal skin itching severity (OCSI Supplementary Question)

    Time frame: From enrollment to end of treatment at 9 weeks

    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.

  8. 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

    Unit of Measure: days

  9. 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

    Unit of Measure: days

  10. 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

    Unit of Measure: percent (%)

  11. 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

    Rated on a 5-point Likert scale from 1 (Very Satisfied) to 5 (Very dissatisfied)

  12. 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

    Rated on a 5-point Likert scale from 1 (Very Satisfied) to 5 (Very dissatisfied)

  13. Ability to correctly use the seal/ring with available instructional resources, assessed by the Study-Specific Instructional Resources Question

    Time frame: From enrollment to the end of treatment at 9 weeks

    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.

  14. Seal swelling/expansion incidence, assessed by Study-Specific Swell/Expand Question

    Time frame: From enrollment to the end of treatment at 9 weeks

    Participant response comparing seal size at application versus at barrier change. Responses: No, seal did not swell/expand / Yes, seal swelled/expanded.

  15. Effectiveness of seal swelling/expansion for secure fit against leakage, assessed by Study-Specific Swell/Expand Question

    Time frame: From enrollment to end of treatment at 9 weeks

    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).

  16. Perceived moisture-wicking effect, assessed by the Study-Specific Moisture-Wicking Question (3-point scale)

    Time frame: From enrollment to the end of treatment at 9 weeks

    Single study-specific question assessing perceived moisture-wicking away from peristomal skin. Responses: No, not at all / Yes, somewhat / Yes, definitely.

  17. Clinician agreement with the study Seal/Ring performance assessed using the Study-Specific Clinician Agreement Questionnaire (Likert scale)

    Time frame: From enrollment to the end of treatment at 9 weeks

    Rated on a 5-point Likert scale from 1 (Strongly agree) to 5 (Strongly disagree)

  18. Quantity of seals/rings, barriers, and accessories used, assessed by Study-Specific Resource Utilization Log

    Time frame: From enrollment to the end of treatment at 9 weeks

    Unit of measure: mean/median number used per participant (counts)

  19. Wear/use time (longevity) of seals/rings and barriers, assessed by Study-Specific Resource Utilization Log

    Time frame: From enrollment to end of treatment at 9 weeks

    Unit of measure: hours or days of wear time per application (time)

  20. Peristomal skin-related unplanned healthcare visits, assessed by Study-Specific Healthcare Utilization Question

    Time frame: From enrollment to end of treatment at 9 weeks

    Unit of measure: number of visits per participant; optionally proportion with ≥1 visit (counts/%)

  21. Total ostomy seal/ring costs, derived from quantities recorded in the Resource and Healthcare Utilization Logs

    Time frame: From enrollment to end of treatment at 9 weeks

    Unit of measure: currency (e.g., dollars)

Study contacts

Contact information is provided by the study sponsor or research team.

John Whitaker; Chief Investigator

CONTACT

[email protected]

024 7696 7148 ext. 27148

Sponsors and collaborators

Lead sponsor

Hollister Incorporated

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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