Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial
Abstract 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 surge...
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Nature Portfolio
2024-11-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-024-77487-3 |
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| author | Peng Luo Qi Lai Li Xu Zhenzhong Chen Runsheng Guo Banglin Xie Ping Yi Zhiying Yang Bin Zhang |
| author_facet | Peng Luo Qi Lai Li Xu Zhenzhong Chen Runsheng Guo Banglin Xie Ping Yi Zhiying Yang Bin Zhang |
| author_sort | Peng Luo |
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| description | Abstract 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. |
| format | Article |
| id | doaj-art-493f40a2d2a94553b9c9b2ba6923e301 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2024-11-01 |
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| spelling | doaj-art-493f40a2d2a94553b9c9b2ba6923e3012024-11-10T12:27:13ZengNature PortfolioScientific Reports2045-23222024-11-0114111210.1038/s41598-024-77487-3Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trialPeng Luo0Qi Lai1Li Xu2Zhenzhong Chen3Runsheng Guo4Banglin Xie5Ping Yi6Zhiying Yang7Bin Zhang8Orthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang UniversityOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang UniversityDepartment of Hepatic-Biliary-Pancreatic Surgery, China-Japan Friendship HospitalDepartment of Orthopedics, Lishui Municipal Central HospitalOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang UniversityOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang UniversityDepartment of Spine Surgery, China-Japan Friendship HospitalDepartment of Hepatic-Biliary-Pancreatic Surgery, China-Japan Friendship HospitalOrthopedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang UniversityAbstract 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.https://doi.org/10.1038/s41598-024-77487-3 |
| spellingShingle | Peng Luo Qi Lai Li Xu Zhenzhong Chen Runsheng Guo Banglin Xie Ping Yi Zhiying Yang Bin Zhang Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial Scientific Reports |
| title | Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial |
| title_full | Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial |
| title_fullStr | Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial |
| title_full_unstemmed | Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial |
| title_short | Efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis: a prospective, randomized controlled trial |
| title_sort | efficacy and safety evaluation of a novel hemostatic gelatin matrix for intraoperative hemostasis a prospective randomized controlled trial |
| url | https://doi.org/10.1038/s41598-024-77487-3 |
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