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Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).
At the baseline visit:
At visit 2:
At each visit from visit 3:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex BorderĀ® | Active Comparator | Mepilex BorderĀ® wound dressing at patients after hip-knee or primary spine surgery |
|
| Cosmopor sterilĀ® | Active Comparator | Standard wound dressing at patients after hip-knee or primary spine surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex BorderĀ® | Device | randomization |
| |
| Cosmopor sterilĀ® |
| Measure | Description | Time Frame |
|---|---|---|
| Minimize the Risk of the Development of Blistering | Number of participants without blisters at study visit | 7 days after surgery |
| 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 |
|---|---|---|
| Jan Bredow | University Hospital Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Cologne | Cologne | North Rhine-Westphalia | 50931 | Germany |
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| Device |
randomization |
|
| 7 days |
| Comfort, Comformability, 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 | 7 days |
| Change From Baseline in Pain on the visual analog scale | Scores range from 0 [no pain] to 10 [worst possible pain] | 7 days |
| the overall cost regarding dressing wear time | bill of material costs | 7 days |