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Clinical Trial
. 2012 Jul;94(5):336-9.
doi: 10.1308/003588412X13171221590971.

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

A Ujam  1 , Z Awad, G Wong, T Tatla, R Farrell
Affiliations
Clinical Trial

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

A Ujam et al. Ann R Coll Surg Engl. 2012 Jul.

Abstract

Introduction: Floseal(®) 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 procedures.

Methods: A 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.

Results: No 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.

Conclusions: Floseal(®) 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.

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