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Polyurethane Foam on the Sacrum for Prevention

Primary Purpose

Hip Fracture, Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hydrocellular polyurethane foam multilayer dressing
standard care
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fracture

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

polyurethane foam

standard care

Arm Description

Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area

Outcomes

Primary Outcome Measures

Number of Participants With Pressure Sores

Secondary Outcome Measures

Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)
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).
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.

Full Information

First Posted
February 23, 2016
Last Updated
March 19, 2019
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT02692482
Brief Title
Polyurethane Foam on the Sacrum for Prevention
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Pressure Ulcer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
359 (Actual)

8. Arms, Groups, and Interventions

Arm Title
polyurethane foam
Arm Type
Experimental
Arm Description
Hydrocellular polyurethane foam multilayer dressing shaped for the sacral area
Arm Title
standard care
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
hydrocellular polyurethane foam multilayer dressing
Other Intervention Name(s)
allevyn life
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Title
Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification
Description
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.
Title
Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Polyurethane Foam on the Sacrum for Prevention

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