Prevention of Pressure Ulcer on the Sacrum (Multischiume)

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

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer Risk
• Intervention / Treatment: Device: Hydrocellular polyurethane foam multilayer dressing; Procedure: Standard preventive care

• Study Type: Interventional
• Enrollment (Actual): 711
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Alessandria, Italy, 15121
    • ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
  • Bologna, Italy, 40133
    • AUSL Bologna Ospedale Maggiore
  • Bologna, Italy, 40138
    • Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
  • Cesena, Italy, 47521
    • AUSL della Romagna
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Reggio Emilia, Italy, 42122
    • Azienda USL- IRCCS di Reggio Emilia
  • Roma, Italy, 00128
    • Policlinico Universitario Campus Bio-Medico di Roma
  • Trento, Italy, 38123
    • APSS Trento
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria Integrata di Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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
Experimental: Hydrocellular polyurethane foam multilayer dressing	Device: Hydrocellular polyurethane foam multilayer dressing; 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; Other Names: ALLEVYN LIFE; Procedure: Standard preventive care; 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
Active Comparator: standard preventive care	Procedure: Standard preventive care; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
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 seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Number of dressing used per patient.		On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2019
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pressure ulcer; Patients at risk; polyurethane foam
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: Multischiume

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No