Efficacy of Topical Hemostatic Agents: A Comparative Evaluation of Two Gelatin/Thrombin-Based Hemostatic Matrices in a Porcine Kidney Surgical Model

J Invest Surg. 2019 Nov;32(7):646-653. doi: 10.1080/08941939.2018.1447619. Epub 2018 Mar 21.

Abstract

Purpose: Topical hemostatic agents are an important means of controlling or preventing bleeding. This study was performed to compare gelatin-thrombin matrix with smooth particles (SmGM) versus gelatin-thrombin matrix with stellate particles (StGM) in a porcine kidney bleeding model. Materials and methods: In male pigs, reproducible lesions (diameter and depth ∼10 mm) were created in the renal cortex. Each lesion was treated topically using either SmGM or StGM. Blood loss was quantified before and 2, 5 and 10 minutes after treatment. Dry mass, ultrastructural and histologic analyses were also performed. Results: Thirty-two lesions were treated with SmGM and 32 with StGM; median initial bleeding rates were 27.6 and 29.1 mL/min, respectively. Two minutes post-application, SmGM was associated with significantly less bleeding than StGM (0.574 vs 0.920 mL/min; p < .0001). This difference stemmed principally from lesions with initial blood loss >29 mL/min, where bleeding rates at 2 minutes were ∼3-fold higher with StGM (1.636 vs 0.567 mL/min; p ≥ 0.040). Dry mass per unit volume of hemostatic agent was significantly higher with SmGM versus StGM. SmGM formed discrete, smooth particles, while StGM particles were stellate and tended to coalesce. Histologic analysis showed more solid mass, larger particles and less intervening space with SmGM versus StGM. Conclusions: In a severe, high-volume bleeding model, residual bleeding at 2 minutes was significantly lower with SmGM versus StGM, and SmGM showed greater consistency across bleeding intensities. These findings may be attributable to dry mass per unit volume and/or ultrastructural differences between the two agents.

Keywords: FloSeal; Surgiflo; animal model; blood loss; hemostasis; surgical bleeding; topical hemostatic agent.

Publication types

  • Comparative Study

MeSH terms

  • Animals
  • Blood Loss, Surgical / prevention & control*
  • Disease Models, Animal
  • Gelatin Sponge, Absorbable / administration & dosage*
  • Hemostasis, Surgical / methods*
  • Humans
  • Kidney / surgery*
  • Male
  • Swine
  • Thrombin / administration & dosage*
  • Treatment Outcome

Substances

  • Thrombin