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Prevention of Pressure Ulcer on the Sacrum (Multischiume)

Primary Purpose

Pressure Ulcer Risk

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

About this trial

This is an interventional prevention trial for Pressure Ulcer Risk focused on measuring Patients at risk, polyurethane foam, pressure ulcer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients at risk to develop Pressure Ulcer (Braden scale <17)
  • without sacrum Pressure Ulcer
  • 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

Sites / Locations

  • ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
  • Ausl Bologna Ospedale Maggiore
  • Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
  • Ausl della Romagna
  • Fondazione IRCCS Policlinico San Matteo
  • Azienda USL- IRCCS di Reggio Emilia
  • Policlinico Universitario Campus Bio-Medico di Roma
  • APSS Trento
  • Azienda Ospedaliera Universitaria Integrata di Verona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydrocellular polyurethane foam multilayer dressing

standard preventive care

Arm Description

Outcomes

Primary Outcome Measures

Rate of any type of pressure ulcer in the sacral area.
The ulcer will be classified 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).

Secondary Outcome Measures

Pressure Ulcer Rate in the Sacral Area of Category≥ II
The ulcer will be classified 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).
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.
Number of dressing used per patient.

Full Information

First Posted
April 1, 2019
Last Updated
February 16, 2021
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT03900455
Brief Title
Prevention of Pressure Ulcer on the Sacrum
Acronym
Multischiume
Official Title
Effectiveness of the Use of a Polyurethane Foam Multilayer Dressing in the Sacral Area, in Addition to Standard Healthcare, to Prevent the Onset of Pressure Ulcer in Patients at Risk. Multicentric Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 19, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer Risk
Keywords
Patients at risk, polyurethane foam, pressure ulcer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Hydrocellular polyurethane foam multilayer dressing
Arm Type
Experimental
Arm Title
standard preventive 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 a multilayer foam with 4 flaps that can be adapted to several areas of the body (including the sacrum) and consists of: an external polyurethane film, which is impermeable to liquids and bacteria using dynamic transpiration, which can form an impenetrable barrier to protect the skin; a protective layer that shields the skin against accidental knocks and helps to spread the pressure; a highly absorbent and leak-proof layer that traps the exudate inside; a layer of hydrocellular polyurethane foam; and, finally, in contact with the skin, a perforated evenly covered layer of silicone gel adhesive. in addition to Standard preventive care
Intervention Type
Procedure
Intervention Name(s)
Standard preventive care
Intervention Description
Pressure Ulcer risk assessment using the Braden scale within 8 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <17, daily inspection of the skin in the various pressure points and moving the patient at list every 4 hours. 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
Rate of any type of pressure ulcer in the sacral area.
Description
The ulcer will be classified 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 seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Secondary Outcome Measure Information:
Title
Pressure Ulcer Rate in the Sacral Area of Category≥ II
Description
The ulcer will be classified 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 seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Title
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 seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Title
Number of dressing used per patient.
Time Frame
On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients at risk to develop Pressure Ulcer (Braden scale <17) without sacrum Pressure Ulcer 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
Facility Information:
Facility Name
ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
Ausl Bologna Ospedale Maggiore
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ausl della Romagna
City
Cesena
ZIP/Postal Code
47521
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda USL- IRCCS di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42122
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
APSS Trento
City
Trento
ZIP/Postal Code
38123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
35124474
Citation
Forni C, Gazineo D, Allegrini E, Bolgeo T, Brugnolli A, Canzan F, Chiari P, Evangelista A, Grugnetti AM, Grugnetti G, Guberti M, Matarese M, Mezzalira E, Pierboni L, Prosperi L, Sofritti B, Tovazzi C, Vincenzi S, Zambiasi P, Zoffoli C, Ambrosi E; Multischiume Group. Effectiveness of a multi-layer silicone-adhesive polyurethane foam dressing as prevention for sacral pressure ulcers in at-risk in-patients: Randomized controlled trial. Int J Nurs Stud. 2022 Mar;127:104172. doi: 10.1016/j.ijnurstu.2022.104172. Epub 2022 Jan 8.
Results Reference
derived

Learn more about this trial

Prevention of Pressure Ulcer on the Sacrum

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