Ostomy
Conditions
Brief summary
Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.
Interventions
DEVICETest Ostomy Barrier
DEVICEControl Ostomy Barrier
Sponsors
Hollister Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ostomy patients who: * Have healthy peristomal skin * Are within 12 weeks post op
Exclusion criteria
Ostomy patients who: * Have a fistula, wound, lesion or suspected infection in the peristomal area * Are in-patient in healthcare facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stoma Related Cost of Care | 12 weeks | 12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peristomal Skin Complication Rate | 8 weeks | Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Ostomy Barrier The test product is a new Hollister ostomy barrier.
Test Ostomy Barrier | 79 |
| Control Ostomy Barrier The control product is a currently marketed Hollister ostomy barrier.
Control Ostomy Barrier | 74 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued Intervention | 15 | 21 |
| Overall Study | Improper Enrollment per In/Ex Criteria | 10 | 6 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Subject withdrawal prior to intervention | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Test Ostomy Barrier | Control Ostomy Barrier | Total |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 24.8 | 57.2 years STANDARD_DEVIATION 15.2 | 56.3 years STANDARD_DEVIATION 15.3 |
| BMI | 24.8 kg/m2 STANDARD_DEVIATION 5.8 | 26.4 kg/m2 STANDARD_DEVIATION 5.8 | 25.6 kg/m2 STANDARD_DEVIATION 5.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 15 participants | 12 participants | 27 participants |
| Region of Enrollment Europe | 8 participants | 9 participants | 17 participants |
| Region of Enrollment United States | 56 participants | 53 participants | 109 participants |
| Sex: Female, Male Female | 29 Participants | 31 Participants | 60 Participants |
| Sex: Female, Male Male | 50 Participants | 43 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 79 | 0 / 74 |
| other Total, other adverse events | 6 / 79 | 11 / 74 |
| serious Total, serious adverse events | 12 / 79 | 6 / 74 |
Outcome results
Primary
Stoma Related Cost of Care
12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.
Time frame: 12 weeks
Population: The analysis population was defined as a modified ITT population which excluded subjects who~1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)~2. did not receive the study device; (n=1)~As such 153 (170-17) subjects were eligible for analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Test Ostomy Barrier | Stoma Related Cost of Care | 223.73 USD |
| Control Ostomy Barrier | Stoma Related Cost of Care | 260.19 USD |
Secondary
Peristomal Skin Complication Rate
Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit.
Time frame: 8 weeks
Population: The analysis population was defined as a modified ITT population which excluded subjects who~1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)~2. did not receive the study device; (n=1)~As such 153 (170-17) subjects were eligible for analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Ostomy Barrier | Peristomal Skin Complication Rate | 32 Participants |
| Control Ostomy Barrier | Peristomal Skin Complication Rate | 41 Participants |