Prevention of Pressure Ulcer on the Sacrum (Multischiume)

• ClinicalTrials.gov Identifier: NCT03900455
• Recruitment Status: Completed
• First Posted: April 3, 2019
• Last Update Posted: February 17, 2021
• Sponsor: Istituto Ortopedico Rizzoli
• Information provided by (Responsible Party): Istituto Ortopedico Rizzoli

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.

Condition or disease	Intervention/treatment	Phase
Pressure Ulcer Risk	Device: Hydrocellular polyurethane foam multilayer dressing; Procedure: Standard preventive care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 711 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: October 21, 2019
• Actual Primary Completion Date: March 12, 2020
• Actual Study Completion Date: March 19, 2020

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. Rate of any type of pressure ulcer in the sacral area. [ Time Frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day ]
   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 :

1. Pressure Ulcer Rate in the Sacral Area of Category≥ II [ Time Frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day ]
   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).
2. Skin irritation/damage due to the adhesive dressing [ Time Frame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day ]
   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.
3. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo

Alessandria, Italy, 15121

Ausl Bologna Ospedale Maggiore

Bologna, Italy, 40133

Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Ausl della Romagna

Cesena, Italy, 47521

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Azienda USL- IRCCS di Reggio Emilia

Reggio Emilia, Italy, 42122

Policlinico Universitario Campus Bio-Medico di Roma

Roma, Italy, 00128

APSS Trento

Trento, Italy, 38123

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy, 37126

Sponsors and Collaborators

Istituto Ortopedico Rizzoli

  Study Documents (Full-Text)

Documents provided by Istituto Ortopedico Rizzoli:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] November 28, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 Jan 8;127:104172. doi: 10.1016/j.ijnurstu.2022.104172. [Epub ahead of print]

• Responsible Party: Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT03900455
• Other Study ID Numbers: Multischiume
• First Posted: April 3, 2019
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Istituto Ortopedico Rizzoli:

Patients at risk; polyurethane foam; pressure ulcer

Additional relevant MeSH terms:

Pressure Ulcer; Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases