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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
711
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
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
ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Ausl Bologna Ospedale Maggiore
Bologna, Italy
Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
Ausl della Romagna
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).
Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
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).
Time frame: 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.
Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Number of dressing used per patient.
Time frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
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Cesena, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Azienda USL- IRCCS di Reggio Emilia
Reggio Emilia, Italy
Policlinico Universitario Campus Bio-Medico di Roma
Roma, Italy
APSS Trento
Trento, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy