Efficacy of hemostatic matrix and microporous polysaccharide hemospheres

Lewis, Kevin M.; Atlee, Holly D.; Mannone, Angela J.; Li, Lin; Goppelt, Andreas

doi:10.1016/j.jss.2014.08.026

Cited by 48 publications

(48 citation statements)

References 24 publications

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“…Floseal™ is a commercial hemostatic agent composed of bovine-derived gelatin matrix and human-derived thrombin isolated from pooled plasma. It can be applied on wet, actively bleeding tissues, conforms to irregular surfaces and has been shown to be more effective than gelfoam in heparinized patients [5]. After application of the Floseal matrix, the gelatin particles swell and tamponade the bleeding as the gelatin matrix-thrombin composite slows the blood flow and provides exposure to a high concentration of thrombin, hastening clot formation [6].…”

Section: Discussionmentioning

confidence: 99%

Can floseal™ be applied safely during otologic surgery? Assessment of ototoxicity in a chinchilla animal model

Nhan

Bezdjian

Alarfaj

et al. 2017

Journal of Otolaryngology - Head & Neck Surgery

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BackgroundIn otologic surgery good visualization is paramount, and patients with bleeding diatheses or who need to be anti-coagulated can present a significant challenge. Here, we determine whether Floseal™, a hemostatic matrix, is ototoxic in a validated animal model.MethodsNine chinchillas housed in the animal care facilities of the Montreal Children’s Hospital Research Institute were used for the study. After a myringotomy incision was made in each tympanic membrane, baseline auditory brainstem response measurements were performed at 8, 20, and 25 kHz. In each animal one ear was randomized to receive Floseal™ to the middle ear cavity, whereas the other ear served as the control and received 0.9% sodium chloride. Outcome measures included early (day 7) and late (day 30) auditory brainstem response, clinical evidence of facial nerve or vestibular disturbance and histological evidence of ototoxity.ResultsThere was no significant hearing threshold shift on auditory brainstem response across all tested frequencies for both experimental and control ear. No animals receiving Floseal™ developed facial or vestibular nerve dysfunction and there was no histological evidence of ototoxicity.ConclusionBased on the preliminary ototoxicity assessment on nine chinchillas, transtympanic Floseal™ does not appear to be ototoxic. More studies are warranted to assess the safety and applicability of the product in humans.

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Section: Discussionmentioning

confidence: 99%

Can floseal™ be applied safely during otologic surgery? Assessment of ototoxicity in a chinchilla animal model

Nhan

Bezdjian

Alarfaj

et al. 2017

Journal of Otolaryngology - Head & Neck Surgery

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“…For the purpose of this study, bleeding scores were measured by a visual, qualitative 6-point scale that has previously been used in other studies [1, 12–14] (Fig. 1), whereby the lower the score, the better the indication of hemostasis outcome.…”

Section: Methodsmentioning

confidence: 99%

Improved bleeding scores using Gelfoam® Powder with incremental concentrations of bovine thrombin in a swine liver lesion model

Morse

Silva

Bartrom

et al. 2016

J Thromb Thrombolysis

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Topical hemostatic agents are used intra-operatively to prevent uncontrolled bleeding. Gelfoam Ò Powder contains a hemostatic agent prepared from purified pork skin gelatin, the efficacy of which is increased when combined with thrombin. However, the effect of increasing concentrations of thrombin on resultant hemostasis is not known. This study sought to evaluate the ability of various concentrations of thrombin in combination with Gelfoam Powder to control bleeding using a swine liver lesion model. Ten pigs underwent a midline laparotomy. Circular lesions were created in the left medial, right medial, and left lateral lobes; six lesions per lobe. Gelfoam Powder was hydrated with Thrombin-JMI Ò diluted to 250, 375, and 770 IU/mL. Each concentration was applied to two lesion sites per lobe. Bleeding scores were measured at 3, 6, 9, and 12 min using a 6-point system; comparison of bleeding scores was performed using ANOVA with the post hoc Tukey test. The bleeding scores with thrombin concentrations at 770 IU/mL were significantly lower than at 250 and 375 IU/mL at all four time points. The percentage of biopsies with a clinically acceptable bleeding score rose from 37.9, 46.6, and 71.2 % at 3 min to 55.2, 69.0, and 88.1 % at 12 min in the 250, 375, and 770 IU/mL thrombin groups, respectively. The study showed that the hemostatic response to thrombin was dose-related: using higher concentrations of thrombin with Gelfoam Powder yielded improved hemostasis, as determined by lower bleeding scores.

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“…One currently available product in this category is a plant-derived starch in a powder formulation containing proprietary microporous polysaccharide hemospheres (TraumaDex; Davol Inc., Warwick, RI) that serve to absorb water and concentrate factors similar to QuikClot but without the exothermic reaction [42]. In addition, this product is also purported to form a gel-like matrix that enhances clot formation.…”

Section: Factor Concentratorsmentioning

confidence: 99%