Prevention of Pressure Ulcer on the Sacrum

Study Overview
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Brief Summary
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The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.

Official Title
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Effectiveness of the Use of a Polyurethane Foam Multilayer Dressing in the Sacral Area, in Addition to Standard Healthcare, to Prevent the Onset of Pressure Ulcer in Patients at Risk. Multicentric Randomized Controlled Trial

Conditions
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Pressure Ulcer Risk

Intervention / Treatment
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* Device: Hydrocellular polyurethane foam multilayer dressing
* Procedure: Standard preventive care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients at risk to develop Pressure Ulcer (Braden scale <17) without sacrum Pressure Ulcer 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

Ages Eligible for Study
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Minimum Age: 18 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: Hydrocellular polyurethane foam multilayer dressing<br> | Device: Hydrocellular polyurethane foam multilayer dressing<br>* Application of a multilayer foam with 4 flaps that can be adapted to several areas of the body (including the sacrum) and consists of: an external polyurethane film, which is impermeable to liquids and bacteria using dynamic transpiration, which can form an impenetrable barrier to protect the skin; a protective layer that shields the skin against accidental knocks and helps to spread the pressure; a highly absorbent and leak-proof layer that traps the exudate inside; a layer of hydrocellular polyurethane foam; and, finally, in contact with the skin, a perforated evenly covered layer of silicone gel adhesive. in addition to Standard preventive care<br>* Other names: ALLEVYN LIFE;Procedure: Standard preventive care<br>* Pressure Ulcer risk assessment using the Braden scale within 8 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <17, daily inspection of the skin in the various pressure points and moving the patient at list every 4 hours. 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 preventive care<br> | Procedure: Standard preventive care<br>* Pressure Ulcer risk assessment using the Braden scale within 8 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <17, daily inspection of the skin in the various pressure points and moving the patient at list every 4 hours. 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 |
| --- | --- | --- |
| Rate of any type of pressure ulcer in the sacral area. | The ulcer will be classified 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 seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Ulcer Rate in the Sacral Area of Category≥ II | The ulcer will be classified 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 seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day | 
| 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 seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day | 
| Number of dressing used per patient. |  | On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients at risk, polyurethane foam, pressure ulcer