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Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial

dc.contributor.authorPeng Luo
dc.contributor.authorQi Lai
dc.contributor.authorLi Xu
dc.contributor.authorZhenzhong Chen
dc.contributor.authorRunsheng Guo
dc.contributor.authorBanglin Xie
dc.contributor.authorPing Yi
dc.contributor.authorZhiying Yang
dc.contributor.authorBin Zhang
dc.contributor.otherOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
dc.contributor.otherOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
dc.contributor.otherDepartment of Hepatic-Biliary-Pancreatic Surgery, China-Japan Friendship Hospital
dc.contributor.otherDepartment of Orthopedics, Lishui Municipal Central Hospital
dc.contributor.otherOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
dc.contributor.otherOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
dc.contributor.otherDepartment of Spine Surgery, China-Japan Friendship Hospital
dc.contributor.otherDepartment of Hepatic-Biliary-Pancreatic Surgery, China-Japan Friendship Hospital
dc.contributor.otherOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University
dc.date.accessioned2024-11-10T12:27:13Z
dc.date.available2025-10-02T05:27:38Z
dc.date.issued01-11-2024
dc.identifier.issn-
dc.identifier.urihttps://doi.org/10.1038/s41598-024-77487-3
dc.description.abstractAbstract Borayflo Haemostatic matrix is a new absorbable hemostatic gelatin matrix which can be used for intraoperative assisted hemostasis. In a prospective, multicenter, non-inferiority, randomized controlled trial, a total of 354 subjects were recruited from the departments of hepatobiliary surgery, obstetrics and gynaecology and orthopaedics of 4 hospitals and randomly allocated to test group (Borayflo Haemostatic matrix) or control group (Surgiflo Haemostatic matrix) in a 1:1 ratio. In the modified intention-to-treat population, 163 (93.14%) of 175 subjects in the test group versus 167 (94.89%) of 176 subjects in the control group successfully achieved hemostasis within 5 min (P > 0.05). Non-inferiority for effective rates of hemostasis at 5 min to Surgiflo Haemostatic matrix was shown in the study (treatment difference: -1.74% [95%CI, -6.70–3.22%] for modified intention-to-treat population). In terms of efficacy and safety, the new hemostatic gelatin matrix (Borayflo Haemostatic matrix) is equivalent to Surgiflo Haemostatic matrix. There was no significant difference in the incidence of AEs or SAEs between the test and control groups(P > 0.05). In addition, Borayflo Haemostatic matrix is a domestically produced haemostatic gelatin product, an advantage that will reduce the cost of surgical haemostasis for Chinese patients.
dc.format-
dc.language.isoEN
dc.publisherNature Portfolio
dc.relation.uri['https://www.springernature.com/gp/open-research/policies/journal-policies/apc-waiver-countries', 'https://bmcanesthesiol.biomedcentral.com/submission-guidelines', 'https://bmcanesthesiol.biomedcentral.com/about', 'https://bmcanesthesiol.biomedcentral.com']
dc.rights['CC BY', 'CC BY-NC-ND']
dc.subject['anaesthesiology', 'pain management', 'anaesthetic mechanisms', 'Anesthesiology', 'RD78.3-87.3']
dc.subject.lccMedicine
dc.titleEfficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial
dc.typeArticle
dc.description.pages1-12
dc.description.doi10.1038/s41598-024-77487-3
dc.title.journalScientific Reports
dc.identifier.e-issn2045-2322
dc.identifier.oaioai:doaj.org/journal:493f40a2d2a94553b9c9b2ba6923e301
dc.journal.infoVolume 14, Issue 1


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