Trials / Completed
CompletedNCT03900455
Prevention of Pressure Ulcer on the Sacrum
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 711 (actual)
- Sponsor
- Istituto Ortopedico Rizzoli · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hydrocellular polyurethane foam multilayer dressing | 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 |
| PROCEDURE | 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 |
Timeline
- Start date
- 2019-10-21
- Primary completion
- 2020-03-12
- Completion
- 2020-03-19
- First posted
- 2019-04-03
- Last updated
- 2021-02-17
Locations
9 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03900455. Inclusion in this directory is not an endorsement.