OstomyNCT07460323
Study of TRE Seals on Early Post-operative Subjects
A study testing An Ostomy Seal and An Ostomy Ring in people with Ostomy, run by Hollister Incorporated at 6 sites in United Kingdom.
Trial summary
This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ostomy
- What is being tested?
- An Ostomy Seal and An Ostomy Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 30 Jun 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Recruiting
William Harvey Hospital
Ashford, Kent, TN24 0LZ
Lalmaya Pun, 1233616646, lalmaya.pun@nhs.net
- Recruiting
University Hospital Coventry
Coventry, West Midlands, CV2 2DX
Michelle Hicken, 024 7696 7148 ext. 27148, michelle.hicken@uhcw.nhs.uk
- Recruiting
Queen Elizabeth The Queen Mother Hospital
Margate, Kent, CT9 4AN
Susan Biles, 1233616646, susan.biles@nhs.net
- Recruiting
East Surrey Hospital
Redhill, Surrey, RH1 5RH
Mathew Varghese, 01737 231728, mathew.varghese8@nhs.net
- Recruiting
East Sussex Healthcare NHS Trust: Conquest and Eastbourne Hospitals
Saint Leonards-on-Sea, East Sussex, TN37 7RD
Janet Sinclair, 7741408250, janet.sinclair4@nhs.net
- Recruiting
North Tees University Hospital
Stockton-on-Tees, County Durham, TS19 8PE
Abdalla Mustafa, 7940211807, abdallamustafa1@nhs.net
About this study
This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.
- Conditions
- Ostomy
- Being tested
- An Ostomy Seal, An Ostomy Ring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An Ostomy SealDevice
An absorptive ostomy seal
An Ostomy RingDevice
The Ostomy Ring contains Aloe
| Study group | Role | What they receive |
|---|---|---|
| An Ostomy Seal | Experimental | Not described Receives: Device: An Ostomy Seal |
| An Ostomy Ring | Active comparator | Not described Receives: Device: An Ostomy Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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/%)
Measured: 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)
Measured: From enrollment to end of treatment at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start30 Jun 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hollister Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Whitaker, Study chair, University Hospital Coventry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460323
- Sponsor's protocol ID
- 6042-OST
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of TRE Seals on Early Post-operative Subjects
- ClinicalTrials.gov ID
- NCT07460323
- Acronym / sponsor ID
- 6042-OST
- Conditions
- Ostomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Hollister IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| An Ostomy Seal | Experimental | Device: An Ostomy Seal |
| An Ostomy Ring | Active comparator | Device: An Ostomy Ring |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An Ostomy SealAn absorptive ostomy seal | Device | An Ostomy Seal |
| An Ostomy RingThe Ostomy Ring contains Aloe | Device | An Ostomy Ring |
Primary outcome
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.
21 secondary outcomes
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
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
Seal swelling/expansion incidence, assessed by Study-Specific Swell/Expand Question
Time frame: 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
Time frame: From enrollment to end of treatment at 9 weeks
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
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
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
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
Peristomal skin-related unplanned healthcare visits, assessed by Study-Specific Healthcare Utilization Question
Time frame: 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
Time frame: From enrollment to end of treatment at 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Whitaker study chair
University Hospital Coventry
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An Ostomy Seal and An Ostomy Ring in people with Ostomy, run by Hollister Incorporated at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Whitaker; Chief Investigator (024 7696 7148 ext. 27148, John.Whitaker@uhcw.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.