NCT07460323

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jun 2026Mar 2027

First Submitted

Initial submission to the registry

February 25, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

February 25, 2026

Last Update Submit

July 22, 2026

Conditions

Ostomy

Outcome Measures

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)

    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 Outcomes (21)

  • 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

  • +16 more secondary outcomes

Study Arms (2)

An Ostomy Seal

EXPERIMENTAL
Device: An Ostomy Seal

An Ostomy Ring

ACTIVE COMPARATOR
Device: An Ostomy Ring

Interventions

An Ostomy SealDEVICE

An absorptive ostomy seal

An Ostomy Seal
An Ostomy RingDEVICE

The Ostomy Ring contains Aloe

An Ostomy Ring

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

North Tees University Hospital

Stockton-on-Tees, County Durham, TS19 8PE, United Kingdom

RECRUITING

East Sussex Healthcare NHS Trust: Conquest and Eastbourne Hospitals

Saint Leonards-on-Sea, East Sussex, TN37 7RD, United Kingdom

RECRUITING

William Harvey Hospital

Ashford, Kent, TN24 0LZ, United Kingdom

RECRUITING

Queen Elizabeth The Queen Mother Hospital

Margate, Kent, CT9 4AN, United Kingdom

RECRUITING

East Surrey Hospital

Redhill, Surrey, RH1 5RH, United Kingdom

RECRUITING

University Hospital Coventry

Coventry, West Midlands, CV2 2DX, United Kingdom

RECRUITING

Study Officials

  • John Whitaker

    University Hospital Coventry

    STUDY CHAIR

Central Study Contacts

John Whitaker; Chief Investigator

CONTACT

024 7696 7148John.Whitaker@uhcw.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 10, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations

GB(6)