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dc.creatorLombardo, Carloes
dc.creatorLopez-Ben, Santiagoes
dc.creatorBoggi, Ugoes
dc.creatorGutowski, Piotres
dc.creatorHrbac, Tomases
dc.creatorKrska, Lukases
dc.creatorMárquez-Rivas, Javieres
dc.creatorRussello, Domenicoes
dc.creatorYork, Elisaes
dc.creatorZacharias, Marioes
dc.date.accessioned2023-05-30T13:01:47Z
dc.date.available2023-05-30T13:01:47Z
dc.date.issued2022-08-20
dc.identifier.citationLombardo, C., Lopez-Ben, S., Boggi, U., Gutowski, P., Hrbac, T., Krska, L.,...,Zacharias, M. (2022). Hemopatch® is effective and safe to use real-world data from a prospective European registry study. Updates in Surgery, 74 (5), 1521-1531. https://doi.org/10.1007/s13304-022-01353-y.
dc.identifier.issn2038-131X; 2038-3312es
dc.identifier.urihttps://hdl.handle.net/11441/146782
dc.description.abstractSurgical procedures are often impeded by bleeding and/or leakage of body fluids. These complications cannot always be resolved by conventional surgical techniques. Hemopatch® is a hemostatic patch that also functions as a sealant. Here we document the effectiveness and safety of Hemopatch® for routine procedures of multiple surgical disciplines. To this end, we performed a prospective, multicenter, single-arm, observational registry study. Patients were eligible if they had received Hemopatch® during an open or minimally invasive procedure in one of these specialties: hepatobiliary, cardiovascular, urological, neurological/spinal, general, or lung surgery. Patients were excluded if they had a known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile or severe bleeding and/or infection at the target application site (TAS). The primary endpoint for intraoperative effectiveness was hemostasis assessed as the percentage of patients achieving hemostasis within 2 min and the percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure. The registry enrolled 621 patients at 23 study sites in six European countries. Six hundred twenty patients had completed follow-up information. Hemostasis within 2 min was achieved at 463 (74.5%) of all 621 TASs. Hemostasis without re-bleeding was observed at 620 (99.8%) TASs. Adverse events were reported in 64 patients (10.3%). This Hemopatch® registry shows that Hemopatch® efficiently establishes hemostasis and sealing in a variety of surgical specialties, including minimally invasive procedures. Furthermore, we provide evidence for the safety of Hemopatch® across all the specialties included in the registry. This study is registered at clinicaltrials.gov: NCT03392662.es
dc.formatapplication/pdfes
dc.format.extent11 p.es
dc.language.isoenges
dc.publisherSpringeres
dc.relation.ispartofUpdates in Surgery, 74 (5), 1521-1531.
dc.rightsAtribución 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectHemopatches
dc.subjectHemostasises
dc.subjectMinimally invasive procedureses
dc.subjectSealinges
dc.titleHemopatch® is effective and safe to use real-world data from a prospective European registry studyes
dc.typeinfo:eu-repo/semantics/articlees
dcterms.identifierhttps://ror.org/03yxnpp24
dc.type.versioninfo:eu-repo/semantics/publishedVersiones
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Cirugíaes
dc.relation.publisherversionhttps://link.springer.com/article/10.1007/s13304-022-01353-yes
dc.identifier.doi10.1007/s13304-022-01353-yes
dc.journaltitleUpdates in Surgeryes
dc.publication.volumen74es
dc.publication.issue5es
dc.publication.initialPage1521es
dc.publication.endPage1531es
dc.contributor.funderBaxteres
dc.contributor.funderBaxter Healthcare SA, Zurich, Switzerlandes
dc.contributor.funderUniversita di Pisa within the CRUI-CARE Agreementes

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Atribución 4.0 Internacional
Except where otherwise noted, this item's license is described as: Atribución 4.0 Internacional