DC Field | Value | Language |
---|---|---|
dc.contributor.author | Choi, Gyu-Seong | ko |
dc.contributor.author | Kim, Seoung Hoon | ko |
dc.contributor.author | Seo, Hyung Ii | ko |
dc.contributor.author | Ryu, Je Ho | ko |
dc.contributor.author | Yun, Sung Pil | ko |
dc.contributor.author | Koh, Mi-Young | ko |
dc.contributor.author | Lee, Moon Sue | ko |
dc.contributor.author | Lee, Haeshin | ko |
dc.contributor.author | Kim, Jae Hun | ko |
dc.date.accessioned | 2021-11-23T06:41:01Z | - |
dc.date.available | 2021-11-23T06:41:01Z | - |
dc.date.created | 2021-11-22 | - |
dc.date.created | 2021-11-22 | - |
dc.date.created | 2021-11-22 | - |
dc.date.created | 2021-11-22 | - |
dc.date.issued | 2021-11 | - |
dc.identifier.citation | ANNALS OF SURGICAL TREATMENT AND RESEARCH, v.101, no.5, pp.299 - 305 | - |
dc.identifier.issn | 2288-6575 | - |
dc.identifier.uri | http://hdl.handle.net/10203/289361 | - |
dc.description.abstract | Purpose: InnoSEAL Plus is an adhesive, coagulant-free hemostatic material that mimics the adhesion mechanism of marine mussels. This study reports on the safety and efficacy of InnoSEAL Plus for patients with hemorrhage after hepatectomy despite first-line hemostasis treatments. Methods: This is a multicenter, prospective, single-blinded, randomized clinical trial involving 96 hepatectomy patients. TachoSil was used as a comparator group. Three-minute and 10-minute hemostatic success rates were monitored. Rebleeding rates were also observed. Safety was assessed by recording all novel undesirable symptoms. Results: InnoSEAL Plus showed a 3-minute hemostasis rate of 100%, while TachoSil had a rate of 98.0% (48 of 49 patients), demonstrating that the 2 had similar hemostatic efficacies. The difference in efficacy between the test and comparator group was 2.04%, and the lower limit of the one-sided 97.5% confidence interval was -1.92%; as this is greater than the noninferiority limit of -23.9%, the 2 treatments were equivalent. Meanwhile, the 10-minute hemostatic success rate was the same in both groups (100%). No rebleeding occurred in either group. In the safety evaluation, 89 patients experienced adverse events (45 in the test group and 44 in the comparator group). The difference between the 2 groups was not significant. No death occurred after application of the test or comparator group product. Conclusion: Given that InnoSEAL Plus is a coagulation factor-free product, the hemostasis results are encouraging, especially considering that TachoSil contains a coagulation factor. InnoSEAL Plus was found to be a safe and effective hemostatic material for control of bleeding in hepatectomy patients. | - |
dc.language | English | - |
dc.publisher | KOREAN SURGICAL SOCIETY | - |
dc.title | A multicenter, prospective, randomized clinical trial of marine mussel-inspired adhesive hemostatic materials, InnoSEAL Plus | - |
dc.type | Article | - |
dc.identifier.wosid | 000717011400006 | - |
dc.identifier.scopusid | 2-s2.0-85119679100 | - |
dc.type.rims | ART | - |
dc.citation.volume | 101 | - |
dc.citation.issue | 5 | - |
dc.citation.beginningpage | 299 | - |
dc.citation.endingpage | 305 | - |
dc.citation.publicationname | ANNALS OF SURGICAL TREATMENT AND RESEARCH | - |
dc.identifier.doi | 10.4174/astr.2021.101.5.299 | - |
dc.identifier.kciid | ART002770562 | - |
dc.contributor.localauthor | Lee, Haeshin | - |
dc.contributor.nonIdAuthor | Choi, Gyu-Seong | - |
dc.contributor.nonIdAuthor | Kim, Seoung Hoon | - |
dc.contributor.nonIdAuthor | Seo, Hyung Ii | - |
dc.contributor.nonIdAuthor | Ryu, Je Ho | - |
dc.contributor.nonIdAuthor | Yun, Sung Pil | - |
dc.contributor.nonIdAuthor | Koh, Mi-Young | - |
dc.contributor.nonIdAuthor | Lee, Moon Sue | - |
dc.contributor.nonIdAuthor | Kim, Jae Hun | - |
dc.description.isOpenAccess | Y | - |
dc.type.journalArticle | Article | - |
dc.subject.keywordAuthor | Clinical trial | - |
dc.subject.keywordAuthor | Hemostatics | - |
dc.subject.keywordAuthor | Hepatectomy | - |
dc.subject.keywordAuthor | Mussel adhesion | - |
dc.subject.keywordAuthor | Validation study | - |
dc.subject.keywordPlus | LIVER RESECTION | - |
dc.subject.keywordPlus | FIBRIN SEALANT | - |
dc.subject.keywordPlus | TACHOSIL | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | SURGERY | - |
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