Hemostatic Effectiveness of Fibrin Pad After Partial Nephrectomy in Swine

Hutchinson, Richard W.; Broughton, Duan; Barbolt, Thomas A.; Poandl, Thomas; Muench, Tim; Rockar, Rick; Johnson, Mark J.; Hart, James

doi:10.1016/j.jss.2010.01.022

Cited by 15 publications

(10 citation statements)

References 19 publications

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“…Many protocols have been established to evaluate ORC materials 192021. Most of these protocols, however, involve application of a topical hemostatic material to separate animals, introducing the possibility that the different hemostatic capacity of each animal could affect bleeding.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Oxidized Regenerated Cellulose, SurgiGuard®, in Porcine Surgery

Kim

Yoon³

et al. 2017

Yonsei Med J

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PurposeAdequate hemostasis is important for postoperative outcomes of abdominal surgery. This study evaluated the hemostatic effects and accompanying histopathological changes of a novel oxidized regenerated cellulose, SurgiGuard®, during abdominal surgery.Materials and MethodsTen pigs underwent wedge resection of the spleen (1×1 cm) and liver (1.5×1.5 cm). The resected surface was covered with Surgicel® fabric or fibril type (Group A) or SurgiGuard® fabric or fibril type (Group B). Surgicel® and SurgiGuard® were randomized for attachment to the resected surface by fabric type (n=5) or fibril type (n=5). Blood loss was measured 5, 7, and 9 min after resection. Pigs were necropsied 6 weeks postoperatively to evaluate gross and histopathological changes.ResultsThere was no significant difference in total blood loss between groups [spleen fabric: Group A vs. Group B, 4.38 g (2.74–6.43) vs. 3.41 g (2.46–4.65), p=0.436; spleen fibril: Group A vs. Group B, 3.44 g (2.82–6.07) vs. 3.60 g (2.03–6.09), p=0.971; liver fabric: Group A vs. Group B, 4.51 g (2.67–10.61) vs. 6.93 g (3.09–9.95), p=0.796; liver fibril: Group A vs. Group B, 3.32 g (2.50–8.78) vs. 3.70 g (2.32–5.84), p=0.971]. Histopathological analysis revealed no significant difference in toxicities related to Surgicel® or SurgiGuard® [inflammation, fibrosis, foreign bodies, and hemorrhage (spleen: p=0.333, 0.127, 0.751, and 1.000; liver: p=0.155, 0.751, 1.000, and 1.000, respectively)].ConclusionSurgiGuard® is as effective and non-toxic as Surgicel® in achieving hemostasis after porcine abdominal surgery.

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Section: Discussionmentioning

confidence: 99%

Efficacy of Oxidized Regenerated Cellulose, SurgiGuard®, in Porcine Surgery

Kim

Yoon³

et al. 2017

Yonsei Med J

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“…Patients and surgeons have recognized that underlying benefits might be produced by the timely control of bleeding, considering the morbidity, mortality and extended hospitalization due to uncontrolled severe traumatic or surgical bleeding [30] . Bleeding insofar as mild, moderate, or even severe intensity can be quickly and successfully treated with traditional mechanical methods (ie, pressure, suturing, ligature, clips and staples) or with various electrosurgical devices in most cases [31] .…”

Section: Discussionmentioning

confidence: 99%

A novel hemostatic sealant composed of gelatin, transglutaminase and thrombin effectively controls liver trauma-induced bleeding in dogs

Xie

Tian

et al. 2013

Acta Pharmacol Sin

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Aim: A novel hemostatic sealant based on the in situ gel formation of gelatin catalyzed by thrombin and crosslinked by transglutaminase was designed. The aim of this study was to investigate the efficacy of the hemostatic sealant in control of bleeding caused by liver trauma in dogs. Methods: Hepatic trauma that mimicked the grade III-IV rupture of liver was made in 20 dogs. The traumatic lesion was topically administered the hemostatic sealant (treatment group, n=10), or a thrombin solution (control group, n=10). The time to achieve hemostasis and the blood loss were measured. Contrast-enhanced ultrasound (CEUS) examination was performed in each animal on d 3, d 7, and d 10 d postoperatively to study the healing of the lesions. Results: The mean time to achieve hemostasis in the treatment group was significantly shorter than that in the control group (1.20±0.33 vs 6.70±0.64 min, P<0.05). The mean blood loss in the treatment group was significantly less than that in the control group (47.22±8.61 vs 79.29±11.97 mL, P<0.05). In CEUS examination, the traumatic lesions in the treatment group became significantly smaller on d 3, and disappeared on d 7, whereas the lesions in the control group still existed on d 10. Ascites were never found during 10 d follow-up in the treatment group but were observed on d 3 and d 7 in the control group. Conclusion: Compared with thrombin, the novel hemostatic sealant shows much better efficacy in hemostasis and may promote wound healing in dog liver trauma.

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“…Fibrin pad is a sterile, bio-absorbable combination product composed of lyophilized human plasma-derived fibrinogen (4.7-12.4 mg/cm 2 ) and thrombin (15-45 IU/cm 2 ), which is similar to EVICEL® Fibrin Sealant [Human] [14,15] coated on a flexible matrix that consists of a woven mesh of oxidized, regenerated cellulose [16] (similar to SURGICEL® Absorbable Hemostats and GYNECARE INTERCEED® Absorbable Adhesion Barrier) of plant origin, with polyglactin 910 (similar to VICRYL TM suture and mesh products) filaments [13] (Figure 1A and 1B) functioning as a mechanical barrier. Fibrin pad was supplied in 10 × 10 cm 2 units and was to be cut to fit the wound site with a margin of 1-2 cm beyond the wound.…”

Section: Methodsmentioning

confidence: 99%

“…It is a sterile, bio-absorbable combination product of a coating of lyophilized biologically active, human thrombin and fibrinogen. A pre-clinical study in a swine partial nephrectomy model demonstrated that direct application of fibrin pad was effective in achieving hemostasis in every animal, with no fibrin pad-related adverse reactions [13]. …”

Section: Introductionmentioning

confidence: 99%

Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

et al. 2012

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BackgroundBleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages.MethodsWe evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level.ResultsPhase I (N = 10): All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled.ConclusionsThe first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage.Trial registrationPhase I/II trial, NCT00598130

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Hemostatic Effectiveness of Fibrin Pad After Partial Nephrectomy in Swine

Cited by 15 publications

References 19 publications

Efficacy of Oxidized Regenerated Cellulose, SurgiGuard®, in Porcine Surgery

Efficacy of Oxidized Regenerated Cellulose, SurgiGuard®, in Porcine Surgery

A novel hemostatic sealant composed of gelatin, transglutaminase and thrombin effectively controls liver trauma-induced bleeding in dogs

Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

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