Prevention of Pressure Ulcer on the Sacrum

Not Applicable

Completed

• Conditions: Pressure Ulcer Risk
• Interventions: Device: Hydrocellular polyurethane foam multilayer dressing; Procedure: Standard preventive care

• Registration Number: NCT03900455
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Study Start: 2019-10-21
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 711

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocellular polyurethane foam multilayer dressing	Standard preventive care	-
Hydrocellular polyurethane foam multilayer dressing	Hydrocellular polyurethane foam multilayer dressing	-
standard preventive care	Standard preventive care	-

Primary Outcome Measures

Name	Time	Method
Rate of any type of pressure ulcer in the sacral area.	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

Name	Time	Method
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	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	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.
Number of dressing used per patient.	On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day

Trial Locations

Locations (9)

APSS Trento; 🇮🇹 Trento, Italy

ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, 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

Azienda Ospedaliera Universitaria Integrata di Verona; 🇮🇹 Verona, Italy

Ausl Bologna Ospedale Maggiore; 🇮🇹 Bologna, Italy