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Polyurethane Foam on the Sacrum for Prevention

NCT02692482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2019-06-19

Study results available
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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.

Conditions

  • Hip Fracture
  • Pressure Ulcer

Interventions

DEVICE

hydrocellular polyurethane foam multilayer dressing

Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care

PROCEDURE

standard care

Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score \<18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02692482 on ClinicalTrials.gov