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Related Experiment Video

Updated: Apr 18, 2026

Author Spotlight: Exploring the Potential of Fat-Derived Stromal Vascular Fraction for Wound Healing

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Published on: November 17, 2023

Fibrocaps for surgical hemostasis: two randomized, controlled phase II trials.

Cornelis Verhoef¹, Neil Singla², Greg Moneta³

¹Department of Surgical Oncology, Erasmus Medical Center Cancer Institute, Rotterdam, The Netherlands.

The Journal of Surgical Research

|January 15, 2015

Summary

Fibrocaps, a novel fibrin sealant, significantly reduced bleeding time in surgical patients compared to gelatin sponge alone. This dry-powder hemostatic agent demonstrated good safety and efficacy, supporting its continued clinical development.

Keywords:

Dry powder Fibrin sealant Fibrinogen and thrombin Hepatic surgery Soft tissue dissection Spinal surgery Vascular surgery

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Characterization of Leukocyte-platelet Rich Fibrin, A Novel Biomaterial

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Published on: September 29, 2015

Area of Science:

Surgical hemostasis
Biomaterials in medicine

Background:

Fibrocaps is a novel, ready-to-use dry-powder fibrin sealant.
It contains human plasma-derived thrombin and fibrinogen.
Fibrocaps is developed as an adjunct for surgical hemostasis.

Purpose of the Study:

To evaluate the safety and efficacy of Fibrocaps compared to gelatin sponge alone.
To assess the time to hemostasis as the primary endpoint.
To investigate Fibrocaps' performance in various surgical procedures.

Main Methods:

Two randomized, single-blind controlled trials (FC-002 US and FC-002 NL) were conducted.
126 adult patients were randomized to receive either Fibrocaps or gelatin sponge alone.
Time to hemostasis was measured, with a 28-day safety follow-up.

Main Results:

Fibrocaps significantly shortened the mean time to hemostasis in both trials (P < 0.001 in US, P = 0.004 in NL).
Higher incidence of hemostasis within 3, 5, and 10 minutes was observed with Fibrocaps.
Adverse events were mild to moderate and similar between groups; 5% of Fibrocaps patients developed non-neutralizing antithrombin antibodies.

Conclusions:

Fibrocaps demonstrated good safety and efficacy.
The results support the continued clinical development of Fibrocaps.
Fibrocaps represents a promising novel fibrin sealant for surgical hemostasis.