dc.creator | Lombardo, Carlo | es |
dc.creator | Lopez-Ben, Santiago | es |
dc.creator | Boggi, Ugo | es |
dc.creator | Gutowski, Piotr | es |
dc.creator | Hrbac, Tomas | es |
dc.creator | Krska, Lukas | es |
dc.creator | Márquez-Rivas, Javier | es |
dc.creator | Russello, Domenico | es |
dc.creator | York, Elisa | es |
dc.creator | Zacharias, Mario | es |
dc.date.accessioned | 2023-05-30T13:01:47Z | |
dc.date.available | 2023-05-30T13:01:47Z | |
dc.date.issued | 2022-08-20 | |
dc.identifier.citation | Lombardo, 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.issn | 2038-131X; 2038-3312 | es |
dc.identifier.uri | https://hdl.handle.net/11441/146782 | |
dc.description.abstract | Surgical 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.format | application/pdf | es |
dc.format.extent | 11 p. | es |
dc.language.iso | eng | es |
dc.publisher | Springer | es |
dc.relation.ispartof | Updates in Surgery, 74 (5), 1521-1531. | |
dc.rights | Atribución 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Hemopatch | es |
dc.subject | Hemostasis | es |
dc.subject | Minimally invasive procedures | es |
dc.subject | Sealing | es |
dc.title | Hemopatch® is effective and safe to use real-world data from a prospective European registry study | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Cirugía | es |
dc.relation.publisherversion | https://link.springer.com/article/10.1007/s13304-022-01353-y | es |
dc.identifier.doi | 10.1007/s13304-022-01353-y | es |
dc.journaltitle | Updates in Surgery | es |
dc.publication.volumen | 74 | es |
dc.publication.issue | 5 | es |
dc.publication.initialPage | 1521 | es |
dc.publication.endPage | 1531 | es |
dc.contributor.funder | Baxter | es |
dc.contributor.funder | Baxter Healthcare SA, Zurich, Switzerland | es |
dc.contributor.funder | Universita di Pisa within the CRUI-CARE Agreement | es |