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
1 other identifier
interventional
711
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 3, 2019
CompletedStudy Start
First participant enrolled
October 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2020
CompletedFebruary 17, 2021
February 1, 2021
5 months
April 1, 2019
February 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Pressure Ulcer Rate in the Sacral Area of Category≥ II
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
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
Study Arms (2)
Hydrocellular polyurethane foam multilayer dressing
EXPERIMENTALstandard preventive care
ACTIVE COMPARATORInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
Alessandria, 15121, Italy
Ausl Bologna Ospedale Maggiore
Bologna, 40133, Italy
Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Ausl della Romagna
Cesena, 47521, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda USL- IRCCS di Reggio Emilia
Reggio Emilia, 42122, Italy
Policlinico Universitario Campus Bio-Medico di Roma
Roma, 00128, Italy
APSS Trento
Trento, 38123, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126, Italy
Related Publications (1)
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.
PMID: 35124474DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 3, 2019
Study Start
October 21, 2019
Primary Completion
March 12, 2020
Study Completion
March 19, 2020
Last Updated
February 17, 2021
Record last verified: 2021-02