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The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenSura | Device | Real life assessment of SenSura |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (Scale 0(Worst)-100(Best)) | The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening. | 6-8 weeks |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Birgitte D Andersen, RN | Herlev Hospital, Dep of colorectal surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Restored Images | Kansas City | Missouri | 64119 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SenSura | Test of SenSura for 6-8 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SenSura | Test of SenSura for 6-8 weeks |
| 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 | Quality of Life (Scale 0(Worst)-100(Best)) | The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening. | ITT | Posted | Mean | Standard Deviation | units on a scale | 6-8 weeks |
|
|
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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 | SenSura | Test of SenSura for 6-8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fistula surgery | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal skin disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helle Aaes Senior Scientific Manager | Coloplast | +45 49112949 | dkheaa@coloplast.com |
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| Physician Decision |
|
| Product dysfunction |
|
| other/unknown reason |
|
| years |
|
| Gender | Gender is unknown for 2 participants | Number | participants |
|
|
|
| 17 |
| 3,017 |
| 58 |
| 3,017 |
| Scar infection | Infections and infestations | Non-systematic Assessment |
|
| General disorders | Non-systematic Assessment | Only the outcome, death, has been registered |
|
| Short bowel syndrome | Gastrointestinal disorders | Non-systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Surgery for ruptured disc | Surgical and medical procedures | Non-systematic Assessment |
|
| Food blokage in the bowel | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Bowel perforation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Placement of nephrostomal cathether | Surgical and medical procedures | Non-systematic Assessment |
|
| Exhaustion | General disorders | Non-systematic Assessment | Due to chemotherapy |
|
| Apoplexia | Nervous system disorders | Non-systematic Assessment |
|
| Cardio respiratory arrest | Cardiac disorders | Non-systematic Assessment | Outcome: death |
|
| Gastrointeritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| General disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
|
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