Polyurethane Foam on the Sacrum for Prevention

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.

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 Overview

• Status: Completed
• Conditions: Hip Fracture; Pressure Ulcer
• Intervention / Treatment: Device: hydrocellular polyurethane foam multilayer dressing; Procedure: standard care

• Study Type: Interventional
• Enrollment (Actual): 359
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.
Experimental: polyurethane foam; Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area	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; Other Names: allevyn life; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Pressure Sores	On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).	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.	On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 23, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries; Skin Ulcer; Femoral Fractures; Hip Injuries; Hip Fractures; Pressure Ulcer
• Other Study ID Numbers: 22022016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No