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The aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU) and their severity especially in the elderly population admitted for fragility Hip Fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polyurethane foam | Experimental | Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area |
|
| standard care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocellular polyurethane foam multilayer dressing | Device | Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pressure Sores | On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf) | On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day. | |
| Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Polyurethane Foam | Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care |
| FG001 | Standard Care | standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polyurethane Foam | Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care |
| BG001 |
| 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 | Number of Participants With Pressure Sores | Posted | Count of Participants | Participants | On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day. |
|
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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 | Polyurethane Foam | Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area hydrocellular polyurethane foam multilayer dressing: Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristiana Forni | Istituto Ortopedico Rizzoli | 0516366694 | 0039 | cristiana.forni@ior.it |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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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 | Procedure | Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure. |
|
Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss). |
| On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day. |
| Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing | Clinical evaluation. It refers to any sort of inflammation and/or discoloration that distorts the skin's normal appearance. The skin may become scaly, bumpy, itchy, or otherwise irritated. | On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day. |
| Standard Care |
standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Number of Participants with Neck Fracture | Count of Participants | Participants |
|
| Braden score | The scale is composed of six subscales that reflect sensory perception, skin moisture, activity, mobility, friction and shear, and nutritional status. Each category is rated on a scale of 1 to 4, excluding the 'friction and shear' category which is rated on a 1-3 scale. This combines for a possible total of 23 points, with a higher score meaning a lower risk of developing a pressure ulcer and vice versa. The critical cut-off point at which the patient could be judged to be at risk for pressure sore formation was a Braden Scale score equal to or less than 16 | Mean | Standard Deviation | units on a scale |
|
|
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| Secondary | Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf) | Posted | Count of Participants | Participants | On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day. |
|
|
|
| Secondary | Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification | Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss). | Posted | Count of Participants | Participants | On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day. |
|
|
|
| Secondary | Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing | Clinical evaluation. It refers to any sort of inflammation and/or discoloration that distorts the skin's normal appearance. The skin may become scaly, bumpy, itchy, or otherwise irritated. | Posted | Count of Participants | Participants | On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day. |
|
|
|
| 2 |
| 177 |
| 0 |
| 177 |
| 0 |
| 177 |
| EG001 | Standard Care | standard care: Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure. | 2 | 182 | 0 | 182 | 0 | 182 |
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| D007869 |
| Leg Injuries |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |