Study of TRE Seals on Early Post-operative Subjects

N/ANot Yet RecruitingNCT07460323

Hollister Incorporated107 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

107

Conditions

Ostomy

Interventions

An Ostomy SealDEVICE

An absorptive ostomy seal

An Ostomy RingDEVICE

The Ostomy Ring contains Aloe

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

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)

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.

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

Secondary Outcomes

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.

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)

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

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)

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

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)

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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Unit of Measure: days

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

Unit of Measure: days

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

Unit of Measure: percent (%)

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)

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

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)

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

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

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.

Time frame: 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.

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

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).

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)

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

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)

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

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

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

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

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

Time frame: 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/%)

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

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

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