Polyurethane Foam on the Sacrum for Prevention

Istituto Ortopedico Rizzoli359 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

359

Conditions

Hip Fracture Pressure Ulcer

Interventions

hydrocellular polyurethane foam multilayer dressingDEVICE

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

standard carePROCEDURE

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

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 Pressure Ulcers in Other Areas (Heel, Back and Calf)

Time frame: 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

Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss).

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

Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing

Clinical evaluation. It refers to any sort of inflammation and/or discoloration that distorts the skin's normal appearance. The skin may become scaly, bumpy, itchy, or otherwise irritated.

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

Data from ClinicalTrials.gov

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