Safety trial of Floseal® haemostatic agent in head and neck surgery

Abstract

INTRODUCTIONFloseal® (Baxter, Hayward, CA, US) can be of value in reducing blood loss and haematoma rates. The manufacturer’s warnings include allergic reaction, poor wound healing and intravascular thrombosis. We aimed to determine whether Floseal® is safe to use in various head and neck surgery (HNS) procedures.METHODSA prospective trial was conducted using Floseal® in 42 various consecutive head and neck surgery procedures. Adverse incidents were used as the main outcome measure, including allergic reaction, wound breakdown, wound infection and thrombosis. Secondary outcome measures included haematoma formation, hospital stay, drain times and output.RESULTSNo adverse incidents were recorded in the trial period. Two patients developed haematomas and required surgical exploration where a bleeding vessel was identified and dealt with.CONCLUSIONSFloseal® is safe to be used in head and neck surgery with no adverse effects. A larger number and a control group are required to ascertain its value in reducing blood loss, haematoma formation, drain usage and hospital stay.

Domiciliary floseal prevents admission for epistaxis in hereditary hemorrhagic telangiectasia

“…More recently FloSeal has been described for other purposes such as providing hemostasis after tonsillectomy with cold steel dissection . Ujam et al studied the incidence of adverse effects when utilizing FloSeal in 42 consecutive head and neck procedures, and found it to be a safe and effective hemostatic agent …”

“…9 Ujam et al studied the incidence of adverse effects when utilizing FloSeal in 42 consecutive head and neck procedures, and found it to be a safe and effective hemostatic agent. 10 Furthermore, FloSeal has been studied in epistaxis with great success when compared to nasal packing. Mathiasen and Cruz compared FloSeal to nasal packing in a prospective, randomized, controlled trial of 70 consecutive patients presenting with acute anterior epistaxis.…”

Magnetic Resonance Imaging Appearance and Mechanism of Action of Five Hemostatic Agents Used in Neurosurgery

“…6 Floseal is a combination gelatin-thrombin tissue sealant composed of human thrombin and bovine-derived gelatin, mixed in saline. 25 Floseal requires reconstitution in calcium chloride before use, 6 which requires 60 seconds of preparation time. It is then extruded like a paste from a syringe to provide more precise application.…”

Efficacy, Security, and Manageability of Gelified Hemostatic Matrix in Bleeding Control during Thoracic and Lumbar Spine Surgery: FloSeal versus Surgiflo

“…[19][20][21] For neurosurgical procedures, only studies that evaluate their efficacy during both brain and spine surgery have been published. 2,5,[22][23][24][25][26][27][28][29][30][31] To date, only one study focused exclusively on the use of a thrombin gelatin hemostatic matrix in spinal surgery (Surgiflo), 32 but there are no comparative studies between the two products in spinal surgery. One study reported on a rat model of laminectomy.…”