A multicenter, prospective, randomized clinical trial of marine mussel-inspired adhesive hemostatic materials, InnoSEAL Plus
10.4174/astr.2021.101.5.299
- Author:
Gyu-Seong CHOI
1
;
Seoung Hoon KIM
;
Hyung Il SEO
;
Je Ho RYU
;
Sung Pil YUN
;
Mi-Young KOH
;
Moon Sue LEE
;
Haeshin LEE
;
Jae Hun KIM
Author Information
1. Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- Publication Type:ORIGINAL ARTICLE
- From:Annals of Surgical Treatment and Research
2021;101(5):299-305
- CountryRepublic of Korea
- Language:English
-
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.
