지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 저널정보
- 대한외과학회 Annals of Surgical Treatment and Research Annals of Surgical Treatment and Research Vol.101 No.5
- 발행연도
- 2021.11
- 수록면
- 299 - 305 (7page)
이용수
초록· 키워드
오류제보하기
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.
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.
목차
INTRODUCTION
METHODS
RESULTS
DISCUSSION
REFERENCES
참고문헌 (15)
참고문헌 신청
Alfieri S / 2001 / Avoiding early postoperative complications in liver surgery: a multivariate analysis of 254patients consecutively observed / Dig Liver Dis 33:341~346
Imamura H / 2003 / One thousand fifty-six hepatectomies without mortality in 8 years / Arch Surg 138:1198~1206
Kubo S / 2007 / Risk factors for massive blood loss during liver resection for hepatocellular carcinoma in patients with cirrhosis / Hepatogastroenterology 54:830~833
Spotnitz WD / 2012 / Hemostats, sealants, and adhesives: a practical guide for the surgeon / Am Surg 78:1305~1321
Ding H / 2013 / Systematic review and meta-analysis of application of fibrin sealant after liver resection / Curr Med Res Opin 29:387~394
Imamura H / 2003 / One thousand fifty-six hepatectomies without mortality in 8 years / Arch Surg 138:1198~1206
Kubo S / 2007 / Risk factors for massive blood loss during liver resection for hepatocellular carcinoma in patients with cirrhosis / Hepatogastroenterology 54:830~833
Spotnitz WD / 2012 / Hemostats, sealants, and adhesives: a practical guide for the surgeon / Am Surg 78:1305~1321
Ding H / 2013 / Systematic review and meta-analysis of application of fibrin sealant after liver resection / Curr Med Res Opin 29:387~394
함께 읽어보면 좋을 논문
논문 유사도에 따라 DBpia 가 추천하는 논문입니다. 함께 보면 좋을 연관 논문을 확인해보세요!
-
Clinical application of a new hemostatic material using mussel-inspired catecholamine hemostat: A pilot study
Annals of Hepato-Biliary-Pancreatic Surgery
2022 .02
-
Advances in the development of hemostatic biomaterials for medical application
생체재료학회지
2021 .12
-
Hemostatic Materials during Operations
대한외과학회 학술대회 초록집
2017 .11
-
ISO 10993 biological evaluation of novel hemostatic powder ? 4SEAL®
생체재료학회지
2022 .06
-
혈액응고인자 제제와 지혈제
대한수혈학회지
2021 .01
-
Viscoelastic coagulation test for liver transplantation
Anesthesia and Pain Medicine
2020 .01
-
In vivo study for the hemostatic efficacy and foreign body reaction of a new powder-type polysaccharide hemostatic agent
Annals of Surgical Treatment and Research
2022 .02
-
소화성 궤양 출혈의 내시경 치료
Korean Journal of Helicobacter Upper Gastrointestinal Research
2018 .01
-
Hemostatic materials in non-variceal upper gastrointestinal hemorrhage
International Journal of Gastrointestinal Intervention
2020 .01
-
Recent Developments in the Endoscopic Treatment of Patients with Peptic Ulcer Bleeding
Clinical Endoscopy
2016 .01
-
Current status and clinical outcome of endoscopic hemostatic powder in gastrointestinal bleeding: a retrospective multicenter study
Clinical Endoscopy
2024 .09
-
Bleeding on the Edge?The Use of Hemostatic Powder for Treating a Bleeding Hypopharyngeal Tumor
Clinical Endoscopy
2021 .01
-
Endoscopic hemostatic powder as a salvage treatment for acute gastrointestinal bleeding
Clinical Endoscopy
2024 .09
-
Effect of flowable thrombin-containing collagen-based hemostatic matrix for preventing pancreatic fistula after pancreatectomy: A randomized clinical trial
Annals of Hepato-Biliary-Pancreatic Surgery
2021 .12
-
Clinical Outcomes of Endoscopic Hemostasis for Bleeding in Patients with Unresectable Advanced Gastric Cancer
Journal of Gastric Cancer
2017 .12
-
Anesthetic management of a chronic liver disease patient with very low platelet counts by considering a rebalanced hemostasis - A case report -
Anesthesia and Pain Medicine
2018 .01
-
Letter to the Editor: A Prospective, Randomized, Controlled Comparative Study of Three Energy Devices in Open Thyroid Surgery: Thunderbeat, Harmonic, and Ligasure
The Journal of Endocrine Surgery
2020 .01
-
Risk Stratification in Cancer Patients with Acute Upper Gastrointestinal Bleeding: Comparison of Glasgow-Blatchford, Rockall and AIMS65, and Development of a New Scoring System
Clinical Endoscopy
2022 .03
-
Effect of an aluminum chloride hemostatic agent on the dentin shear bond strength of a universal adhesive
Restorative Dentistry and Endodontics
2023 .05
-
Rescue fibrin glue-infiltrating hemostasis combined with hepatorrhaphy to control intractable postoperative bleeding from the liver cut surface
Annals of Hepato-Biliary-Pancreatic Surgery
2021 .11
이 논문의 저자 정보
최근 본 자료
댓글(0)
0
UCI(KEPA) : I410-ECN-0101-2021-514-002136022