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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 711
- Locations
- 18
- Primary Endpoint
- Rate of any type of pressure ulcer in the sacral area.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Rate of any type of pressure ulcer in the sacral area.
Time Frame: 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 Outcomes
- 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)
- 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)
- Number of dressing used per patient.(On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day)