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Haemostasis in Spinal Surgery
human thrombin component has the potential to induce allergic repeat applications are necessary with FloSeal. Preparation and
responses, this has not been observed in clinical trials.
13
application are quick and easy: generally, the product can be prepared
and ready for use in less than a minute.
17
Of the haemostatic agents that
In a multicentre clinical study, 127 patients undergoing discectomies, we use in the hospital, we have found FloSeal to be the most effective
fusions and decompression surgeries were randomised to the in diffuse intra-spinal bleeding, which may also occur in routine intra-
experimental haemostatic treatment of FloSeal or the control treatment spinal procedures such as decompression surgery. Therefore, in cases of
of Gelfoam–thrombin.
14
In spite of the treatment group exhibiting more pertinacious intra-spinal bleeding, application of FloSeal represents the
aggressive bleeding, FloSeal showed a significantly greater ability to treatment of choice. In major vessel bleeding, our experience is that
control bleeding at all sites within 10 minutes of application (99% FloSeal is a good adjunct to suture ligation.
success; p<0.001) and significantly shorter time to haemostasis than the
control group (1.5 versus three minutes). Although not statistically FloSeal saves time in surgery by reducing intra-operative bleeds,
significant, the experimental group also had higher haematocrit levels 24 especially in microscopic techniques. This reduces revision rates by
hours following surgery, indicating superior control over blood loss. No lowering the incidence of epidural haematomas. If revision surgery is
statistically significant difference was found between the treatment and necessary, such as in the case of recurrent disc herniations, and FloSeal
control groups for the length of surgery (p=0.26), although there was a was used in the primary intervention, our experiences have indicated a
consistent trend favouring FloSeal for shorter procedures. Surgeons also trend towards reduced post-operative adhesion intra-spinally.
reported that FloSeal was easier to use in terms of general application, Histological studies support these findings.
18
FloSeal can be used for
ability of the product to conform to the target site and application to up to two hours intra-operatively, which makes it a useful agent in
difficult-to-reach areas. The incidence and types of adverse events were multilevel decompression cases. By reducing OR time, the use of
similar between the treatment groups, indicating comparable safety haemostatic agents favours patient outcome and recovery and
profiles for FloSeal and Gelfoam–thrombin. This study was the spinal presents cost–benefit advantages to all.
cohort of a larger multispeciality study comprising a total of 309 patients
undergoing spinal, cardiac and vascular surgery,
15
in which the efficacy of Conclusion
FloSeal in moderate to severe bleeding was demonstrated. Pooled results The method of haemostatic control depends largely on circumstance
from across the specialities demonstrated that, in spite of the equivalent and the source of blood loss. For larger surgeries, it is not always necessary
success rates between the treatment and control groups (FloSeal 96% to go beyond the traditional techniques of clamping, cautery and suture
versus Gelfoam–thrombin 77%; p<0.001 in the Blackwelder and Chang ligation, although topical haemostatic agents are useful adjuncts. There is
test),
16
FloSeal was significantly more effective in stopping bleeding. a growing tendency towards microsurgical techniques in spinal surgery
because of the multiple benefits, including reduced intra-operative
Haemostatic Agents in the Clinical Setting bleeding, thus resulting in an enhanced patient outcome. In ALIF
In our own operating room (OR), we commonly use FloSeal and Gelfoam procedures, where macroscopic and mini-open techniques are sufficient,
and, less frequently, the purified plant polysaccharide Arista™ (Medafor) chemical haemostatic agents are rarely used, although they represent an
in controlling haemostasis. We find FloSeal and Gelfoam are equivalent important adjunct. Concomitant with the growing use of microsurgical
in their ease of use, although FloSeal must be compressed upon techniques is the ever-increasingly important role of haemostatic agents,
application and monitored for the swelling of the gelatine matrix. In as seen in the common use in microscopically assisted PLIF.
terms of efficacy, FloSeal stops bleeds more quickly and effectively than
the other mentioned agents. Unlike Arista, which can cause intra-spinal Regardless of the haemostatic agent used, the most important
scar tissue formation if not removed completely, FloSeal can be left at element in controlling blood loss is patience to ensure that complete
the wound site after excess amounts not integrated into the clot are haemostasis is achieved to obtain the best possible outcome. Surgeons
gently rinsed away. While Gelfoam can also theoretically be left in place, will invariably have their reasons for selecting one haemostatic agent
in our hospital we routinely completely remove the gelatine sponge to over another, be it personal preference or type of surgery and the
prevent post-operative compression of the neurostructures. However, musculature and tissues involved. Ultimately, the efficacy and safety of
this removal can disrupt the clot formed at the tissue–Gelfoam interface the haemostatic agent should be weighted with regards to the
and result in recurrent bleeding. Rarely in surgery have we found that benefits presented to the patient. ■
1. Sabel S, Stummer W, The use of local agents: surgical and 7. Rauzzino MJ, Shaffrey CI, Wagner J, et al., Surgical approaches 13. FloSeal Hemostatic Matrix Instructions for Use, Baxter
surgifoam, Eur Spine J, 2004;13:S97–101. for the management of idiopathic thoracic scoliosis and the Healthcare, 2005.
2. Maroon JC, Current concepts in minimally invasive discectomy, indications for the combined anterior-posterior technique, 14. Renkens KL, Payner TD, Leipzig TJ, et al., A multicenter,
Neurosurgery, 2002;51(Suppl. 2):137–45. Neurosurg Focus, 1999;6(5):6. prospective randomized trial evaluating a new hemostatic agent
3. Baker JK, Reardon PR, Reardon MJ, et al., Vascular injury in 8. Seraph V, Lerch C, Walochnik N, et al., Comparison of for spinal surgery, Spine, 2001;26(15):1645–50.
anterior lumbar surgery, Spine, 1993;18:2227–30. conventional versus minimally invasive extraperitoneal 15. Oz MC, Rondinone JF, Shargill NS, Floseal matrix: new
4. Faciszewski T, Winter RB, Lonstein JE, et al., The surgical and approach for anterior lumbar interbody fusion, Eur Spine J, generation topical hemostatic sealant, J Card Surg, 2003;18:
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5. Kozak JA, Heilman AE, O’Brien JP, Anterior lumbar interbody 108–13. 17. Fiss I, Danne M, Stendel R, Use of gelatin-thrombin matrix
fusion options: techniques and graft materials, Clin Orthop, 10. Park Y, Ha JW, Comparison of one-level posterior lumbar hemostatic sealant in cranial neurosurgery, Neurol Med Chir
1994;300:45–51. interbody fusion performed with a minimally invasive approach (Tokyo), 2007;47:462–7.
6. Kuslich SD, Ulstrom CL, Griffith SL, et al., The Bagby and or a traditional open approach, Spine, 2007;32(5):537–43. 18. Miyamoto K, Masuda K, Inoue N, et al., Anti-adhesion
Kuslich method of lumbar interbody fusion. History, techniques 11. Lawson JH, The clinical use and immunologic impact of thrombin properties of a thrombin-based hemostatic gelatin in a canine
and two-year follow-up results of a US prospective, multicenter in surgery, Semin Thromb Hemost, 2006;32:S98–110. laminectomy model: a biomechanical, biochemical and
trial, Spine, 1998;23:1267–78. 12. Gelfoam Sponge Physician Information, Pfizer, 07/2007. histologic study, Spine, 2006;31(4):E91–E97.
EUROPEAN MUSCULOSKELETAL REVIEW 39
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