Polyurethane Foam on the Sacrum for Prevention

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Hip Fracture; Pressure Ulcer

Treatments: Procedure: standard care; Device: hydrocellular polyurethane foam multilayer dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT02692482

22022016

Details and patient eligibility

About

The aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU) and their severity especially in the elderly population admitted for fragility Hip Fractures.

Enrollment: 359 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients aged ≥ 65 years with Hip fragility fracture without National Pressure Ulcers Advisory Panel scale (NPUAP) scale grade ≥ II PU
• 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
• Patients with peri-prosthetic or pathological fractures
• Patients with diaphyseal or distal femoral fractures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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359 participants in 2 patient groups

polyurethane foam

Experimental group

Description:

Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area

Treatment:

Device: hydrocellular polyurethane foam multilayer dressing

Procedure: standard care

standard care

Active Comparator group

Treatment:

Procedure: standard care