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

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:

• animal model
• blood loss
• FloSeal
• hemostasis
• surgical bleeding
• Surgiflo
• topical hemostatic agent

ACKNOWLEDGMENTS

We would like to thank Kevin M. Lewis DVM for reviewing the manuscript, Dr Sylvia Nürnberger for her support with histology, and Jernej Hren DVM for surgical support.

DECLARATION OF INTEREST

The authors report conflicts of interest. HR and PS are CEOs of Trauma Care Consult GmbH, the organization that received the funding to conduct the study. DS and HG are full time employees of Baxter Medical Products GmbH. All other authors have no conflicts of interest to declare. The studies reported here were designed and performed using established scientific methods with impartial data collection and analysis. The authors are responsible for the content of the article. Meridian HealthComms Ltd provided writing assistance, which was paid for by Baxter Healthcare Corporation.

Additional information

Funding

This study was funded by Baxter Healthcare Corporation. Medical writing support was provided by Meridian HealthComms, funded by Baxter Healthcare Corporation.