A multicenter, prospective, randomized clinical trial of marine mussel-inspired adhesive hemostatic materials, InnoSEAL Plus
- Authors
- Choi, GS[Choi, Gyu-Seong]; Kim, SH[Kim, Seoung Hoon]; Seo, H[Seo, Hyung Ii]; Ryu, JH[Ryu, Je Ho]; Yun, SP[Yun, Sung Pil]; Koh, MY[Koh, Mi-Young]; Lee, MS[Lee, Moon Sue]; Lee, H[Lee, Haeshin]; Kim, JH[Kim, Jae Hun]
- Issue Date
- Nov-2021
- Publisher
- KOREAN SURGICAL SOCIETY
- Keywords
- Clinical trial; Hemostatics; Hepatectomy; Mussel adhesion; Validation study
- Citation
- ANNALS OF SURGICAL TREATMENT AND RESEARCH, v.101, no.5, pp.299 - 305
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- ANNALS OF SURGICAL TREATMENT AND RESEARCH
- Volume
- 101
- Number
- 5
- Start Page
- 299
- End Page
- 305
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/90655
- DOI
- 10.4174/astr.2021.101.5.299
- ISSN
- 2288-6575
- 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.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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