Pressure Ulcer Risk
Conditions
Keywords
Patients at risk, polyurethane foam, pressure ulcer
Brief summary
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.
Interventions
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
PROCEDUREStandard 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
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of any type of pressure ulcer in the sacral area. | On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pressure Ulcer Rate in the Sacral Area of Category≥ II | On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day | 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). |
| Skin irritation/damage due to the adhesive dressing | On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day | 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. |
| Number of dressing used per patient. | On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day | — |
Countries
Italy
Outcome results
None listed