Effectiveness of a multi-layer silicone-adhesive polyurethane foam dressing as prevention for sacral pressure ulcers in at-risk in-patients: Randomized controlled trial.

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Publisher: Elsevier B.V.
Document Type: Report
Length: 1,008 words

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Keywords Clinical trials; Controlled trials; General dermatology; Pressure ulcers; Advanced wound dressing; Prevention Abstract Background There is need for improvement in effective pressure ulcers preventive strategies. Objective To study whether a multi-layer silicone-adhesive polyurethane foam dressing shaped for the sacrum prevents PUs development in addition to standard PU preventive care for at-risk hospitalized patients. Design Open-label, parallel group, multi-center randomized controlled trial. Participants and setting 709 in-hospital patients at risk for pressure ulcers from 25 medical, surgical, and intensive care units of 12 Italian hospitals. Methods A multi-layer silicone-adhesive polyurethane foam was applied to the sacrum in addition to standard PUs preventive care in the intervention group. In the control group, standard preventive care alone, including systematic pressure ulcer risk assessment, skin assessment three times per day, routine positioning every 4 h, use of active support surface as appropriate, and incontinence skin care, was guaranteed. Primary outcome was incidence of sacral pressure ulcers of any stage at seven days from hospital admission. Secondary outcomes were incidence of sacral pressure ulcers [greater than or equal to] II stage, number of days needed to PU development, number of skin adverse events due to the foam dressing, number of dressings used for each patient, number of withdrawing patients due to discomfort caused by the foam dressing. Participants were evaluated at baseline and at seven days. Results In patients admitted to medical units, 15/113 controls and 4/118 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 9.2%; NNT for benefit 11, 95% CI 6 to 44). In patients admitted to surgical units, 21/144 controls and 8/142 in the intervention group developed sacral pressure ulcers (p = 0.010; absolute reduction 8.9%; NNT for benefit 11 95% CI 6 to 49). Pressure ulcers incidence was not significantly different between the randomization arms (5.2% experimental vs 10.4% control, p = 0.141) in patients admitted to intensive care units. Overall, 46/358 (12.8%) controls and 17/351 (4.8%) in the intervention group developed sacral pressure ulcers (p Conclusion A sacral multi-layer silicone-adhesive polyurethane foam in addition to standard preventive care is effective for pressure ulcers prevention in at-risk hospitalized patients admitted to medical and surgical units. TRIAL REGISTRATION: ClinicalTrials.gov NCT03900455. The registration (April 1st, 2019) occurred before the first patient was enrolled (October 21st, 2019). Author Affiliation: (a) Head of the Nursing and Allied Profession Research Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy (b) Staff Nurse, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola -- Malpighi, Bologna, Italy (c) Nurse Executive of Health Professions, Azienda Ospedaliera Universitaria Integrata, Verona, Italy (d) Coordinator of HTA Unit, Department of Research, Training and Innovation, Azienda Ospedaliera Nazionale S.S. Antonio e Biagio e C. Arrigo, Alessandria, Italy (e) Head of Centre of Higher Education for Health Sciences, Azienda Provinciale per I Servizi Sanitari di Trento, Trento, Italy (f) Associate Professor, Department of Diagnostics and Public Health, University of Verona, Verona, Italy (g) Associate Professor Alma Mater, University of Bologna, Bologna, Italy (h) General Affairs Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy (i) Coordinator of Degree and Master's Degree Courses in Health Professions and Research, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (j) Nurse Executive of Health Professions, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (k) Nurse Executive of Health Professions, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy (l) Associate Professor, Research Unit of Nursing Sciences, Campus Bio-Medico, University of Rome, Roma, Italy (m) Research Fellow, Department of Diagnostics and Public Health, University of Verona, Verona, Italy (n) Organizational Representative, Nursing and Technical Direction, AUSL Romagna ambito di Rimini, Rimini, Italy (o) Clinical teacher, Centre of Higher Education for Health Sciences, Azienda Provinciale per I Servizi Sanitari di Trento, Trento, Italy (p) Chief Nurse, Orthopaedics, Ospedale Maggiore AUSL Bologna, Italy (q) Nurse Executive, Provincial Hospital Service, Azienda Provinciale per I Servizi Sanitari di Trento, Trento, Italy (r) Coordinator of the Master of Science in Nursing, Azienda Ospedaliera Universitaria Integrata, Verona, Italy (s) Chief Nurse, Care Process Governance Service, Azienda Provinciale per I Servizi Sanitari di Trento, Trento, Italy (t) Organizational Representative, Wound Care Specialist Network, AUSL Romagna ambito di Cesena, Cesena, Italy (u) Senior Assistant Professor, Department of Diagnostics and Public Health, University of Verona, Verona, Italy (v) Wound Care Specialist, AUSL Romagna- Ambito di Cesena, Cesena, Italy (w) Wound Care Specialist, AUSL Romagna- Ambito di Cesena, Cesena, Italy (x) Chief Nurse, Azienda Ospedaliera Nazionale S.S. Antonio e Biagio e C. Arrigo, Alessandria, Italy (y) Staff Nurse, AUSL Romagna- Ambito di Rimini, Rimini, Italy (z) Case Manager, Ospedale Maggiore AUSL Bologna, Bologna, Italy (aa) Staff Nurse, AUSL Romagna- Ambito di Cesena, Cesena, Italy (bb) Wound Care Specialist, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy (cc) Chief Nurse, AUSL Romagna- Ambito di Cesena, Cesena, Italy (dd) Staff Nurse, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy (ee) Wound Care Specialist, Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola -- Malpighi, Bologna, Italy (ff) Staff Nurse, AUSL Romagna- Ambito di Rimini, Rimini, Italy (gg) Physiotherapist, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy (hh) Chief Nurse, Azienda Ospedaliera Nazionale S.S. Antonio e Biagio e C. Arrigo, Alessandria, Italy * Correspondence to Elisa Ambrosi, Department of Diagnostics and Public Health, University of Verona, Verona, Italy. Strada le Grazie 8, Verona, 37134. Article History: Received 24 July 2021; Revised 20 December 2021; Accepted 3 January 2022 Byline: Cristiana Forni [cristiana.forni@ior.it] (a), Domenica Gazineo [domenica.gazineo@aosp.bo.it] (b), Elisabetta Allegrini [elisabetta.allegrini@aovr.veneto.it] (c), Tatiana Bolgeo [tbolgeo@ospedale.al.it] (d), Anna Brugnolli [anna.brugnolli@apss.tn.it] (e), Federica Canzan [federica.canzan@univr.it] (f), Paolo Chiari [paolo.chiari@unibo.it] (g), Andrea Evangelista [andrea.evangelista@ior.it] (h), Anna Maria Grugnetti [a.grugnetti@smatteo.pv.it] (i), Giuseppina Grugnetti [g.grugnetti@smatteo.pv.it] (j), Monica Guberti [monica.guberti@ausl.re.it] (k), Maria Matarese [m.matarese@unicampus.it] (l), Elisabetta Mezzalira [elisabetta.mezzalira@univr.it] (m), Lara Pierboni [lara.pierboni@auslromagna.it] (n), Letizia Prosperi [letizia.prosperi@apss.tn.it] (o), Barbara Sofritti [b.sofritti@ausl.bo.it] (p), Cristina Tovazzi [cristina.tovazzi@apss.tn.it] (q), Silvia Vincenzi [silvia.vincenzi@univr.it] (r), Paola Zambiasi [paola.zambiasi@apss.tn.it] (s), Carlotta Zoffoli [carlotta.zoffoli@auslromagna.it] (t), Elisa Ambrosi [elisa.ambrosi_01@univr.it] (u,*)

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Gale Document Number: GALE|A695646050