Ostomy
Conditions
Brief summary
This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.
Interventions
DEVICEAn Ostomy Seal
An absorptive ostomy seal
DEVICEAn Ostomy Ring
The Ostomy Ring contains Aloe
Sponsors
Hollister Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Risk of Peristomal Skin Complications (PSCs) as measured using the three PSC-related questions on the Ostomy Complication Severity Index (OCSI) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | The leakage item on the OCSI has a scale of 0 (no leakage) to 3 (leakage approximately 1-2 times per day) |
| Visible moisture/effluent on peristomal skin under the study seal area (OCSI Supplementary Question) | 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). |
| Seal absorption of moisture/effluent under the study seal area (OCSI Supplementary Question) | 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). |
| Presence of peristomal skin conditions (OCSI Supplementary Question) | 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. |
| Peristomal skin burning severity (OCSI Supplementary Question) | 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. |
| Peristomal skin itching severity (OCSI Supplementary Question) | 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. |
| 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 | From first PSC onset to resolution through end of treatment at 9 weeks | Unit of Measure: days |
| Time to recurrence of peristomal skin complications (PSCs) after resolution, assessed by the OCSI at visits and AE reports between visits | From PSC resolution to first recurrence through end of treatment at 9 weeks | Unit of Measure: days |
| Proportion of participants with PSC occurrence, PSC resolution, and PSC recurrence, assessed by the OCSI at visits and AE reports between visits | From enrollment to end of treatment at 9 weeks | Unit of Measure: percent (%) |
| Patient satisfaction with the study Seal/Ring assessed using the Study-Specific Patient Satisfaction Questionnaire (Likert scale) | 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) |
| Clinician Satisfaction with the study Seal/Ring assessed using the Study-Specific Clinician Satisfaction Questionnaire (Likert scale) | 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) |
| Ability to correctly use the seal/ring with available instructional resources, assessed by the Study-Specific Instructional Resources Question | 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. |
| Seal swelling/expansion incidence, assessed by Study-Specific Swell/Expand Question | 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. |
| Effectiveness of seal swelling/expansion for secure fit against leakage, assessed by Study-Specific Swell/Expand Question | 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). |
| Perceived moisture-wicking effect, assessed by the Study-Specific Moisture-Wicking Question (3-point scale) | 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. |
| Clinician agreement with the study Seal/Ring performance assessed using the Study-Specific Clinician Agreement Questionnaire (Likert scale) | 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) |
| Quantity of seals/rings, barriers, and accessories used, assessed by Study-Specific Resource Utilization Log | From enrollment to the end of treatment at 9 weeks | Unit of measure: mean/median number used per participant (counts) |
| Wear/use time (longevity) of seals/rings and barriers, assessed by Study-Specific Resource Utilization Log | From enrollment to end of treatment at 9 weeks | Unit of measure: hours or days of wear time per application (time) |
| Peristomal skin-related unplanned healthcare visits, assessed by Study-Specific Healthcare Utilization Question | From enrollment to end of treatment at 9 weeks | Unit of measure: number of visits per participant; optionally proportion with ≥1 visit (counts/%) |
| Total ostomy seal/ring costs, derived from quantities recorded in the Resource and Healthcare Utilization Logs | From enrollment to end of treatment at 9 weeks | Unit of measure: currency (e.g., dollars) |
Countries
United Kingdom
Contacts
CONTACTJohn Whitaker; Chief Investigator
STUDY_CHAIRJohn Whitaker
University Hospital Coventry
Outcome results
None listed