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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocellular polyurethane foam multilayer dressing | Experimental |
| |
| standard preventive care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocellular polyurethane foam multilayer dressing | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Ulcer Rate in the Sacral Area of Category≥ II | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASO Azienda Ospedaliera Nazionale SS Antonio e Biagio e Cesare Arrigo | Alessandria | 15121 | Italy | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35124474 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 28, 2018 | Apr 1, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Standard preventive care | Procedure | 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 |
|
| 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 | 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. | 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 |
| 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 |