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This study will evaluate two Ostomy Seals/Rings in a group of post-operative patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| An Ostomy Seal | Experimental |
| |
| An Ostomy Ring | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| An Ostomy Seal | Device | An absorptive ostomy seal |
| |
| An Ostomy Ring |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Device |
The Ostomy Ring contains Aloe |
|
| 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) |
| 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). | 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). | 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. | 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. | 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. | 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 | 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 | 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 (%) | 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) | 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) | 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. | 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. | 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). | 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. | 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) | 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) | 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) | 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/%) | 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) | From enrollment to end of treatment at 9 weeks |