Prevention of Pressure Ulcer on the Sacrum

Pressure Ulcer Risk Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900455
• Other study ID #: Multischiume
• Status: Completed
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: March 19, 2020

Study information

• Verified date: February 2021
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: March 19, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcer Risk
• Ulcer

Intervention

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

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of dressing used per patient.		On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day