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Benefits of the Floseal® matrix in haemostasis

Atheer Ujam and Zaid Awad
1 July, 2013  
This article describes the benefits and safety of Floseal® matrix for haemostasis in a number of surgical specialties
Atheer Ujam BDS MBBS MFDS MRCS DOHNS
Kings College Hospital NHS Trust,
London, UK
Zaid Awad MBChB DOHNS FRCS
(ORL-HNS)
ENT Surgery,
Imperial College Healthcare NHS Trust, London UK
Floseal® (Baxter Healthcare) is formed of bovine-derived gelatin granules coated in human thrombin. Floseal® is supplied as a gelatin matrix and human-derived thrombin component that require mixing prior to application. It is applied to the surgical site from a syringe as a high-viscosity gel that is adherent to wet surfaces. Floseal® should be applied to the site of bleeding and left for two minutes, before any excess is gently irrigated away. The final material is excellent at conforming to irregular surgical cavities and clot formation is promoted by the presence of thrombin.
The manufacturer provides exact details for the correct use of the gel and its use should not replace conventional haemostatic measures. The use of other traditional haemostasis techniques such as clips, bipolar diathermy and suture ties and newer techniques such as the Harmonic® scalpel (Ethicon Endo-Surgery, Cincinnati, US) should always be considered and used primarily. The final additional step to traditional insertion of a drain and multilayer closure is for the surgeon to spray Floseal® into the wound as an adjunct to reduce postoperative haemorrhage and haematoma formation.
This article aims to describe the benefits and the safety of Floseal® in both general terms and within each surgical specialty. 
General benefits and safety
The clinical evidence for Floseal® was established in 2000 following the published work of Oz and colleagues.(1) 
Theirs was a small study of 93 patients undergoing cardiac surgery and it was demonstrated that, compared with gelfoam, Floseal® was statistically significantly better at stopping bleeding. Later, in 2003, this effectiveness was further demonstrated in a controlled randomised, multicentre study in cardiac, vascular and spinal surgery.
The benefits of Floseal® can be easily appreciated when conventional techniques fail to achieve haemostasis or where bleeding is from a widespread surgical site. The matrix can be easily applied to the site and can stop oozing, spurting, large surgical sites and both hard and soft tissues. Bleeding is controlled quickly within a few minutes with the Floseal® expanding by 20% by ten minutes. 
The documented adverse events relating to the use of Floseal®, include anaemia, atrial fibrillation, infection and bleeding.
There is evidence to support the association of Floseal® use with unwanted effects and complications, especially if not used in the correct manner for the right indication. Furthermore, excessive use or spread of Floseal® into areas not requiring haemostasis can also lead to complications detrimental to the surgical outcome, complications clearly identified by the manufacturer. The manufacturer’s warnings include allergic reaction, poor wound healing and intravascular thrombosis.
Specific warnings with regards to safety include:
  • Should not be used intravascularly – do not inject into veins or arteries
  • Avoid in patients with known bovine allergies
  • Avoid in areas of active infection
  • Floseal® has not been fully tested in ophthalmology procedures – to be avoided.
  • No safety data in pregnancy and children
  • The thrombin component can be denatured by alcohol, iodine or heavy metal ions
  • Floseal® should not be allowed to enter cell saving and bypass equipment 
  • Avoid Floseal® contact with skin edges as poor healing may occur.
Head and neck surgery
At present, the regular use of haemostatic sealants is not established within this field of surgery, unlike other surgical specialties such as neurosurgery, where it is used in the majority of all cranial and spinal surgery routinely. Ujam and colleagues(2) looked at the safety of Floseal® in a mixture of head and neck procedures ranging from parotidectomy to thyroidectomy and found that there were no adverse effects or allergic reaction in a group of 42 patients. The complex anatomy of the head and neck region, and the potential risk to the airway from bleeding, requires meticulous attention to bleeding. Therefore, the role of Floseal® as an adjunct to current haemostatic control to reduce such risks is clearly advantageous. 
Within the literature, there are several reports of Floseal® use in otolaryngology procedures such as control of epistaxis, tonsillectomy, sinus surgery and thyroid surgery. Generally, outcomes measures are in support for using Floseal®, and in particular to reduce postoperative bleeding, quicker healing and less pain. However, there are reports of postoperative complications such as increased healing and granulation tissue leading to synechia formation and increased adhesions in following sinus surgery.
Cardiothoracic surgery
The benefits of Floseal® were initially demonstrated in cardiac surgery where significantly reduced rates of bleeding were recorded. Since then, further research has shown that using Floseal® in cardiac surgery can reduce the need for transfusion of blood products and the rate of revision for bleeding. Furthermore, there is evidence to suggest that Floseal® can reduce length of hospital stay compared to other haemostatic agents.(3,4) Nasso et al published their work on a prospective randomised clinical trial on the use of Floseal® in cardiac and thoracic surgery.(4)
 
They demonstrated that Floseal® is associated with statistically significant higher rates of haemostasis, reduced postoperative bleeding and rates of blood transfusion.
Neurosurgery
Floseal® has been used for over a decade in neurosurgical procedures and is almost used routinely as a prophylactic precaution to prevent bleeding postoperatively. Commonly used at the end of neurosurgical procedures, the use of Floseal® is well established in this field.
Gazzeri et al have extensively reported on the use of Floseal® in neurosurgical procedures. Their work shows that, not only is Floseal® safe to use in neurosurgical procedures, but it can also be used in several clinical scenarios ranging from controlling bleeding following an intracerebral haematoma with no underlying vascular anomaly through to spinal surgery. They also demonstrate a reduced operative time.(5)
Buchowski et al reports on two cases of epidural spinal cord compression with neurologic deficit associated with intrapedicular application of haemostatic gelatin matrix during pedicle screw insertion.(6) Both patients required further surgery to evacuate Floseal® from the spinal canal and made a full recovery, but this highlights some potential dangers of Floseal® in such cases.
General/pelvic surgery
The benefits of using Floseal® within general surgical procedures are also well documented. For example, there are numerous reports within the literature of its use in blunt splenic trauma to help achieve haemostasis, controlling presacral venous haemorrhage, reducing operative time within vascular surgery and reduce bleeding, operative time and the need for blood transfusion in myomectomy surgery.(7)
There are publications on adverse effects of the use of Floseal®, including small bowel obstruction, excessive synechia formation, excessive postoperative pain, foreign body reaction resulting in caseating granulomas and microcalcifications mimicking malignancy.(8) Shashoua et al reported a case of Floseal® causing caseating granulomas in the pelvis and abdomen of a patient who had undergone a laparoscopic hysterectomy. These mimicked metastatic disease but were, in fact, Floseal® gel particles causing a foreign body reaction leading to giant cell granulomas.(9)
 
In 2009 Thomas and Tawfic reported on three cases of postoperative pelvic pain in patients who had undergone pelvic surgery. The report describes how a possible allergic eosinophil rich inflammatory response may have resulted in excessive formation of granulation tissue and fibrosis.(10)
 
Conclusions
Floseal® has been used in surgery to help control bleeding and achieve haemostasis for over ten years. The literature shows good evidence to support its use as an effective and safe product when used correctly in accordance with the manufacturer’s guidelines. At the same time, surgeons should be fully aware of possible side effects and complications to prevent unwanted results. 
Besides being an effective haemostatic agent, Floseal® has other advantages. By achieving effective and predictable haemostasis, the use of Floseal® can result in several potential benefits:
  • Less operative time
  • Improved utilisation of theatre time 
  • Quicker anaesthetic time and recovery
  • Reduced inpatient hospital stay 
  • Reduced rates of postoperative bleeding requiring further surgery
  • Reduced costs and need for blood transfusions.
The cost of Floseal® is approximately £140 (€170) per pack, which is typically enough for one patient undergoing most surgical procedures. The cost of increased hospital admission due to postoperative bleeding is vastly more than this, when the cost of increased stay and return to surgery is considered. Indeed, if patients can be discharged even a day sooner for a given operation, then the cost of using Floseal® is justified and seen as a money-saving practice. The evidence appears to be in favour of Floseal® as an effective haemostatic agent and, given its extensive use over many years, it has been convincingly proven to be safe. 
References 
  1. Oz MC et al. Controlled clinical trial of a novel hemostatic agent in cardiac surgery. The Fusion Matrix Study Group. Ann Thorac Surg 2000 May;69(5):1376–82.
  2. Ujam A et al. Safety trial of Floseal(®) haemostatic agent in head and neck surgery. Ann R Coll Surg Engl 2012;94(5):336–9. 
  3. Krishnan S et al. Choice of hemostatic agent and hospital length of stay in cardiovascular surgery. Semin Cardiothorac Vasc Anesth 2009;13(4):225–30.
  4. Nasso G et al. Prospective, randomized clinical trial of the FloSeal matrix sealant in cardiac surgery. Ann Thorac Surg 2009;88(5):1520–6.
  5. Gazzeri R, Galarza M, Alfier A. The safety and biocompatibility of gelatin hemostatic Matrix (Floseal and Surgiflo) in neurosurgical procedures. Surg Technol Int 2012 Sep 1;XXII.
  6. Buchowski JM et al. Epidural spinal cord compression with neurologic deficit associated with intrapedicular application of hemostatic gelatin matrix during pedicle screw insertion. Spine 2009;34(13):E473–7.
  7. Raga F et al. Reducing blood loss at myomectomy with use of a gelatin-thrombin matrix hemostatic sealant. Fertil Steril 2009;92(1):356–60.
  8. Henkel A et al. Malignant-appearing microcalcifications at the lumpectomy site with the use of FloSeal hemostatic sealant. AJR Am J Roentgenol 2008;191(5):1371–3.
  9. Shashoua AR et al. Caseating granulomata caused by hemostatic agent posing as metastatic leiomyosarcoma. JSLS 2009;13(2):226–8.
  10. Thomas PJ, Tawfic SN. Eosinophil-rich inflammatory response to FloSeal hemostatic matrix presenting as postoperative pelvic pain. Am J Obstet Gynecol 2009;200(4):e10-1.