Polyurethane Foam on the Sacrum for Prevention

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of the Use of a New Polyurethane Foam Multilayer Dressing in the Sacral Area to Prevent the Onset of Pressure Sores in the Elderly With Hip Fractures. Randomized Controlled Trial.

Conditions
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Hip Fracture, Pressure Ulcer

Intervention / Treatment
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* Device: hydrocellular polyurethane foam multilayer dressing
* Procedure: standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥ 65 years with Hip fragility fracture without National Pressure Ulcers Advisory Panel scale (NPUAP) scale grade ≥ II PU Patients or legal guardians who give their consent to take part in the study Exclusion Criteria Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products Patients with peri-prosthetic or pathological fractures Patients with diaphyseal or distal femoral fractures

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: polyurethane foam<br>Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area | Device: hydrocellular polyurethane foam multilayer dressing<br>* 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<br>* Other names: allevyn life;Procedure: standard care<br>* 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.<br>|
| Active Comparator: standard care<br> | Procedure: standard care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |