Clinical trial NCT03900455: Prevention of Pressure Ulcer on the Sacrum
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer Risk
Keywords: Patients at risk
polyurethane foam
pressure ulcer
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 711
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Rate of any type of pressure ulcer in the sacral area.
timeFrame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Secondary outcomes:
measure: Pressure Ulcer Rate in the Sacral Area of Category≥ II
timeFrame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
measure: Skin irritation/damage due to the adhesive dressing
timeFrame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
measure: Number of dressing used per patient.
timeFrame: On the seventh day of hospitalization or upon discharge from hospital, if that occurs before the seventh day
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo
city: Bologna
country: Italy
facility: Ausl Bologna Ospedale Maggiore
city: Bologna
country: Italy
facility: Policlinico di S.Orsola Azienda Ospedaliero-Universitaria di Bologna
city: Cesena
country: Italy
facility: Ausl della Romagna
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Reggio Emilia
country: Italy
facility: Azienda USL- IRCCS di Reggio Emilia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico di Roma
city: Trento
country: Italy
facility: APSS Trento
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
Study officials:
References:
citation: 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.