Prevention of Pressure Ulcer on the Sacrum

NACompletedINTERVENTIONAL
Enrollment

711

Participants

Timeline

Start Date

October 21, 2019

Primary Completion Date

March 12, 2020

Study Completion Date

March 19, 2020

Conditions
Pressure Ulcer Risk
Interventions
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

Trial Locations (9)

15121

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

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

37126

Azienda Ospedaliera Universitaria Integrata di Verona, Verona

38123

APSS Trento, Trento

40133

Ausl Bologna Ospedale Maggiore, Bologna

40138

Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna, Bologna

42122

Azienda USL- IRCCS di Reggio Emilia, Reggio Emilia

47521

Ausl della Romagna, Cesena

00128

Policlinico Universitario Campus Bio-Medico di Roma, Roma

All Listed Sponsors
lead

Istituto Ortopedico Rizzoli

OTHER

NCT03900455 - Prevention of Pressure Ulcer on the Sacrum | Biotech Hunter | Biotech Hunter