Prevention of Pressure Ulcer on the Sacrum (Multischiume)

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Pressure Ulcer Risk

Treatments: Procedure: Standard preventive care; Device: Hydrocellular polyurethane foam multilayer dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03900455

Multischiume

Details and patient eligibility

About

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.

Enrollment: 711 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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711 participants in 2 patient groups

Hydrocellular polyurethane foam multilayer dressing

Experimental group

Treatment:

Procedure: Standard preventive care

Device: Hydrocellular polyurethane foam multilayer dressing

standard preventive care

Active Comparator group

Treatment:

Procedure: Standard preventive care