Effectiveness of the Use of a New Polyurethane Foam Multilayer Dressing in the Sacral Area to Prevent the Onset of Pressure Sores in the Elderly With Hip Fractures. Randomized Controlled Trial.

Istituto Ortopedico Rizzoli1 site in 1 country359 target enrollmentMarch 2016

ConditionsHip Fracture Pressure Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hip Fracture
Sponsor: Istituto Ortopedico Rizzoli
Enrollment: 359
Locations: 1
Primary Endpoint: Number of Participants With Pressure Sores
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

December 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Istituto Ortopedico Rizzoli

Responsible Party

Sponsor

Eligibility 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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Number of Participants With Pressure Sores

Time Frame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

Secondary Outcomes

Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing(On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.)
Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification(On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.)
Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)(On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.)