Fibrin sealant patch provides better hemostasis during liver resection

Last Updated: 2016-01-06

By Will Boggs MD

NEW YORK (Reuters Health) - Fibrin sealant patches (FSP) provide better secondary control of local bleeding than cellulose patches in patients undergoing liver resection, researchers report.

"There are no standards of care in how to accomplish liver hemostasis," Dr. Yuri Genyk from Keck Medical Center of the University of Southern California, Los Angeles, told Reuters Health by email. "Having said that, FSP in this study was found to be very effective and the hemostasis was accomplished in 100% of patients at 10 minutes."

Topical hemostatic agents like fibrin sealant and cellulose are widely used for the control of bleeding during hepatic surgery when standard surgical techniques prove insufficient, Dr. Genyk and colleagues write in the Journal of the American College of Surgeons, online December 17.

The team compared the efficacy and safety of FSP (TachoSil, Takeda Pharma) and absorbable oxidized regenerated cellulose gauze (ORCG; Surgicel Original, Ethicon) as secondary treatment for hemostasis in a randomized, open-label study of 224 adults and 29 children at 19 US centers.

Among adults, hemostasis within three minutes was achieved by 80.7% of the FSP group versus 50.0% of the ORCG group (p<0.001). The proportion of patients with hemostasis at five minutes was also significantly higher with FSP than with ORCG (94.7% vs. 76.4%, p<0.001).

After five minutes, 14.0% of FSP patients and 22.9% of ORCG patients had a second patch applied; by 10 minutes all patients in the FSP group had achieved hemostasis, whereas 10.9% of ORCG patients still had visible bleeding.

Mean time to hemostasis was significantly shorter with FSP than with ORCG (3.5 min vs. 5.5 min, p<0.001).

The FSP and ORCG groups did not differ significantly in mean operating time, admittance to the ICU after surgery, mean ICU length of stay, mean hospital length of stay, or treatment-emergent adverse events. More ORCG patients (13.6%) than FSP patients (9.6%) required surgical reintervention.

Results among children followed a similar pattern. More patients in the FSP group (17/20, 85.0%) than in the ORCG group (4/9, 44.4%) achieved hemostasis at three minutes. By five minutes, all but one FSP patient had achieved hemostasis, compared with seven of the nine ORCG patients.

All FSP patients achieved hemostasis by 10 minutes, while one ORCG patient did not and required rescue treatment.

"This product is effective, easy to use, it is ready for use off the package, and requires no preparation or mixing," Dr. Genyk said. He added that he might favor ORCG over FSP for "patients with difficult hemostasis, liver injury, coagulopathy."

Takeda Pharma A/S sponsored the study and employed one of the seven authors of this report. Takeda also paid for preparation of the manuscript.

SOURCE: http://bit.ly/1JXi96j

J Am Coll Surg 2015.