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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Ostomy Barrier | Other | The test product is a new Hollister ostomy barrier. |
|
| Control Ostomy Barrier | Other | The control product is a currently marketed Hollister ostomy barrier. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Ostomy Barrier | Device |
| ||
| Control Ostomy Barrier |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Ostomy patients who:
Exclusion Criteria:
Ostomy patients who:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kalifa | Hollister Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stoia Consultants | Riverside | California | 92508 | United States | ||
| Jupiter Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Ostomy Barrier | The test product is a new Hollister ostomy barrier. Test Ostomy Barrier |
| FG001 | Control Ostomy Barrier | The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population was defined as a modified ITT population which excluded subjects who
As such 153 (170-17) subjects were eligible for analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Ostomy Barrier | The test product is a new Hollister ostomy barrier. Test Ostomy Barrier |
| BG001 | Control Ostomy Barrier | The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis population was defined as a modified ITT population which excluded subjects who
As such 153 (170-17) subjects were eligible for analysis | Posted | Least Squares Mean | 95% Confidence Interval | USD | 12 weeks |
|
12 weeks
Adverse Events were determined via standardized study investigator assessment forms. All Adverse Events are reported irrespective of relation to study product.
Adverse Events were reported for the modified ITT population which excluded subjects who
As such AEs reported for 153 (170-17) subjects
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Ostomy Barrier | The test product is a new Hollister ostomy barrier. Test Ostomy Barrier |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elective colonoscopy | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacy Haddad, Global Clinical Affairs Director | Hollister Incorporated | 847-680-2837 | stacy.haddad@hollister.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2016 | Mar 29, 2018 | Prot_SAP_000.pdf |
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|
| 8 weeks |
| Jupiter |
| Florida |
| 33458 |
| United States |
| Winter Haven Hospital | Winter Haven | Florida | 33881 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Indiana Health Ball Memorial University | Muncie | Indiana | 47303 | United States |
| Restored Images | Kansas City | Missouri | 64119 | United States |
| Klein's Orthopedic & Medical Supply | Cuyahoga Falls | Ohio | 44223 | United States |
| St. Elizabeth Hospital | Youngstown | Ohio | 44504 | United States |
| Lakeside Medicine Center | Kelowna | British Columbia | V1M 3C2 | Canada |
| Pharmasave | Nanaimo | British Columbia | V9S 5W4 | Canada |
| Ostomy Care Centre | New Westminster | British Columbia | V3M 2T5 | Canada |
| Rouge Valley Health System | Toronto | Ontario | M1E 489 | Canada |
| Withdrawal by Subject |
|
| Subject withdrawal prior to intervention |
|
| Improper Enrollment per In/Ex Criteria |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG001 | Control Ostomy Barrier | The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier |
|
|
| 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. | The analysis population was defined as a modified ITT population which excluded subjects who
As such 153 (170-17) subjects were eligible for analysis | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 2 |
| 79 |
| 12 |
| 79 |
| 6 |
| 79 |
| EG001 | Control Ostomy Barrier | The control product is a currently marketed Hollister ostomy barrier. Control Ostomy Barrier | 0 | 74 | 6 | 74 | 11 | 74 |
| Death due to septic shock | Infections and infestations | Systematic Assessment |
|
| Pelvic Abscess | Infections and infestations | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Intestinal Blockage/Illeus | Gastrointestinal disorders | Systematic Assessment |
|
| Acute shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Death due to primary cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Inflamed gall bladder | Gastrointestinal disorders | Systematic Assessment |
|
| Non-specific Failure to Thrive | General disorders | Systematic Assessment |
|
| Non-specific Pain | Renal and urinary disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Incisional Abscess | Infections and infestations | Systematic Assessment |
|
| Intestinal Blockage/Illeus | Gastrointestinal disorders | Systematic Assessment |
|
| Stoma abrasion caused by patient | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ostomy pouching system not secure | Product Issues | Systematic Assessment |
|
| Peristomal Skin Complication | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Stoma complication | Gastrointestinal disorders | Systematic Assessment |
|
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