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The overall rationale for this study is to evaluate the clinical performance potential for Mepilex Border Post-Op in the ability to minimise the risk of blistering, maceration and less dressing change due to high absorption capacity. This study is a part of Post Market Clinical Follow-Up (PMCF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dressing | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex border post. op | Device |
| ||
| Mepilex border post op |
| Measure | Description | Time Frame |
|---|---|---|
| Minimize the Risk of the Development of Blistering. | Number of participants without blisters at study visit | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing. | The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kourosh Zarghooni, Dr. Med | University Hospital Koln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| universitätsklinikum Köln | Cologne | Köln | 50924 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dressing | Mepilex border post. op Mepilex border post op |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dressing | Mepilex border post. op Mepilex border post op |
| 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 | Minimize the Risk of the Development of Blistering. | Number of participants without blisters at study visit | Number | participants | 7 days |
|
|
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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 | Dressing | Mepilex border post. op Mepilex border post op |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| •Cardiac disorders | Cardiac disorders | suspicion of heart attack, no relation to the study product |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kourosh Zarghooni | Klinik und Poliklinik für Orthopädie und Unfallchirurgie der Uniklinik Köln | +49 2247887294 | kourosh.zarghooni@uk-koeln.de |
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|
| 7 days |
| Comfort, Comformability, Acceptability of the Dressing | 7 days |
| Pain Evaluation | 7 days |
| Overall Cost Regarding Dressing Wear Time | 7 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing. | The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery | Number | participants | 7 days |
|
|
|
| Secondary | Comfort, Comformability, Acceptability of the Dressing | 7 days |
| Secondary | Pain Evaluation | 7 days |
| Secondary | Overall Cost Regarding Dressing Wear Time | 7 days |
| 2 |
| 60 |
| 0 |
| 60 |
| surgical and medical procedures | Surgical and medical procedures | reoperation due to implantdislocation, no relation to the study product |
|
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