Efficacy of Flowable Collagen Hemostat Evaluated in Preclinical Models of Liver Injury and Spinal Cord Exposure

Medical Devices: Evidence and Research, 2023 · DOI: https://doi.org/10.2147/MDER.S411735 · Published: June 5, 2023

Cardiovascular Science Surgery Biomedical

Simple Explanation

This study evaluates a new flowable collagen-based product, compared to the original flour formulation, for hemostatic efficacy in preclinical models of solid organ injury and spinal cord exposure. The flowable microfibrillar collagen was shown to yield favorable short- and long-term outcomes in representative applications where hemostatic efficacy is critical to surgical success. The primary objective of this study was to compare the hemostatic potentialthis study was to compare the hemostatic potential and local tissue responses to this novel, flowable collagen-based hemostatic agent to the original flour formulation.

Study Duration

120 days

Participants

36 Yorkshire swine and 37 sheep

Evidence Level

Not specified

Key Findings

1
The flowable MCH flour mixed with saline provided more precise application and uniform coverage to injured tissues compared to the dry MCH flour alone.
2
The flowable and dry MCH flour exhibited comparable 100% acute hemostatic efficacy and similar long-term histomorphological properties in a capsular resection liver injury in pigs.
3
In an ovine model, the flowable and dry MCH flour again exhibited comparable results without any neurological effects.

Research Summary

This study evaluated the hemostatic ability of AviteneTM Flowable Collagen Hemostat, produced by combining a modified version of AviteneTM MCH flour with sterile saline. In a porcine model of liver injury, animals were treated with flowable collagen (FL), dry collagen flour (F0), or gauze and observed for up to 120 days. In an ovine model of spinal cord injury, animals were treated with either flowable collagen (FL) or dry collagen flour (F0) and evaluated after 45, 90, or 120 days.

Practical Implications

Precise Application

Flowable collagen allows for more precise and uniform coverage of injured tissues compared to dry flour.

Comparable Efficacy

Flowable collagen demonstrates comparable hemostatic efficacy to dry flour in liver and spinal cord injury models.

Reduced Swelling

Flowable collagen formulations may be well-suited for hemostatic applications in surgical regions where access and swelling may be a concern, such as spinal surgery.

Study Limitations

1
Only one product was included as a comparison group (gauze).
2
Data acquired at earlier (<30 days) and/or later (>120 days) times would perhaps yield additional insights.
3
Only one ratio of solid product to saline volume was evaluated (1 g flour with 7 mL saline).

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