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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00694-51 | Other Identifier | 2018-A00694-51 |
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| Name | Class |
|---|---|
| Molnlycke Health Care AB | INDUSTRY |
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The study is a randomised controlled trial of patients admitted for a scheduled cardiac surgery at the Clermont-Ferrand hospital.
Patients meeting the study inclusion criteria will be allocated to either the control group that will receive pressure ulcer prevention standard care or the intervention group that will receive pressure ulcer prevention standard care plus have a Mepilex® Border dressing applied to their sacrum.
The main objective of this research is to evaluate the impact of Mepilex Border® dressing applied in addition to standard pressure ulcer prevention protocol, in a French hospital setting, in at-risk patients in a cardiovascular surgery unit with full hospitalisation including block operation and ICU.
Hypothesis: Patients treated with Mepilex® Border dressings will have a lower incidence rate of sacral pressure ulcer development than patients receiving standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Other | pressure ulcer prevention standard care |
|
| standard care + Mepilex® Border | Experimental | pressure ulcer prevention standard care + Mepilex® Border applied on sacrum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex® Border dressing | Combination Product | Soft silicone self-adherent dressing (5-layers) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pressure ulcer incidence | Incidence of sacral pressure ulcers acquired during patients' hospital stay | 0-20 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise LACLAUTRE | Contact | 04 73 75 49 63 | drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Franck HENTZ | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D012883 | Skin Ulcer |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Other | The control group will receive pressure ulcer prevention standard care |
|