Published: 2021-03-26

Augmentation of dural closure following cerebro-spinal surgeries using Evicel- an experience of 105 patients in India

Batuk D. Diyora, Nilesh More, Gagan Dhali


Background: For the neurosurgeon, CSF leaks are a frustrating post-operative complication, and for the patient, it can result in unanticipated morbidity and mortality. Immediate intra-operative recognition of incidental durotomy and dural closure may avoid it. Fibrin sealant is a two-component topical hemostat, dura sealant, and tissue adhesive consisting of fibrinogen and thrombin. We conducted this study to evaluate the efficacy of fibrin sealant Evicel in the management of postoperative CSF leaks as an adjunct to dural suture in patients undergoing a variety of neurosurgical procedures.

Methods: This was a retrospective, single-center clinical study conducted on 105 patients who underwent elective neurological surgery from August 2015 to May 2016 at Sion Hospital, India. The efficacy endpoint was the prevention of clinically evident and verified postoperative CSF leak.

Results: In all patients, the dural defect was effectively repaired intraoperatively, indicated by the absence of CSF leakage. The success rate of using Evicel was 100% in our cohort for the durasealant efficacy. No adverse effects were reported.

Conclusions: We conclude that the use of fibrin sealant Evicel was successful to manage CSF leaks and achieve predictable watertight dural closure resulting in a reduction of intraoperative and postoperative fluid collections. It possesses an acceptable safety profile, consistent with previous findings from other similar studies and studies evaluating the role of Evicel in other surgical indications.


Cerebrospinal fluid leak, Cerebro-spinal surgery, Dural repair, Dural sealant system, Fibrin glue, Fibrin sealant, Incidental durotomy

Full Text:



Jones AA, Stambough JL, Balderston RA, Rothman RH, Booth RE. Long-term results of lumbar spine surgery complicated by unintended incidental durotomy. Spine. 1989;14:443-6.

Rampersaud YR, Moro ER, Neary MA, White K, Lewis SJ, Massicotte EM, et al. Intraoperative adverse events and related postoperative complications in spine surgery: implications for enhancing patient safety founded on evidence-based protocols. Spine. 2006;31:1503-10.

Tafazal SI, Sell PJ. Incidental durotomy in lumbar spine surgery: incidence and management. Eur Spine J. 2005;14:287-90.

Biroli F, Fusco M, Bani GG, Signorelli A, Esposito F, de Divitiis O, et al. Novel equine collagen-only dural substitute. Neurosurgery. 2008;62:273-4.

Cavallo LM, Messina A, Esposito F, de Divitiis O, Dal Fabbro M, de Divitiis E, et al. Skull base reconstruction in the extended endoscopic transsphenoidal approach for suprasellar lesions. J Neurosurg. 2007;107:713-20.

Wiesel SW. The multiply operated lumbar spine. Instr Course Lect. 1985;34:68-77.

Bosacco SJ, Gardner MJ, Guille JT. Evaluation and treatment of dural tears in lumbar spine surgery: a review. Clin Orthop Relat Res. 2001;389:238-47.

Tafazal SI, Sell PJ. Incidental durotomy in lumbar spine surgery: incidence and management. Eur Spine J. 2005;14:287-90.

Tamašauskas A, Šinkūnas K, Draf W, Deltuva V, Matukevičius A, Rastenytė D, et al. Management of cerebrospinal fluid leak after surgical removal of pituitary adenomas. Medicina. 2008;44(4):302.

Koo J, Adamson R, Wagner FC, Jr, Hrdy DB. A new cause of chronic meningitis: infected lumbar pseudomeningocele. Am J Med. 1989;86:103-4.

Verner EF, Musher DM. Spinal epidural abscess. Med Clin North Am. 1985;69:375-84.

Allen KP, Isaacson B, Kutz JW, Purcell PL, Roland PS. The association of meningitis with postoperative cerebrospinal fluid fistula. J Neurol Surg B Skull Base. 2012;73:401-4.

Grotenhuis JA. Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases. Surg Neurol. 2005;64:490-4.

Jones AA, Stambough JL, Balderston RA, Rothman RH, Booth RE. Long-term results of lumbar spine surgery complicated by unintended incidental durotomy. Spine. 1989;14:443-6.

Spontnitz WD. Fibrin sealant: past, present, future. A brief review. World J Surg. 2010;34:632-4.

Carless PA, Henry DA, Anthony DM. Fibrin sealant use for minimising peri-operative allogeneic blood transfusion. Cochrane Database Syst Rev. 2003;CD004171.

Dolenc VV. Effectiveness of fibrin glue for preventing postoperative extradural fluid leakage (comments). Neurol Med Chir. 1997;37(12):886-90.

Rousou JA. Use of fibrin sealants in cardiovascular surgery: a systematic review. J Card Surg. 2013;28(3):238-47.

Carless P, Henry D. Systematic review and meta‒analysis of the use of fibrin sealant to prevent seroma formation after breast cancer surgery. Br J Surg. 2006;93:810-9.

Por YC, Shi L, Samuel M, Song C, Yeow VKL. Use of tissue sealants in face-lifts: a metaanalysis. Aesthet Plast Surg. 2009;33:336-9.

Thoms RJ, Marwin SE. The role of fibrin sealants in orthopaedic surgery. J Am Acad Orthop Surg. 2009;17:727-36.

Sierra DH. Fibrin sealant adhesive systems: a review of their chemistry, material properties and clinical applications. J Biomater Appl. 1993;7:309-52.

Lam F, Penumaka A, Chen C, Fischer E, Kasper E. Fibrin sealant augmentation with autologous pericranium for duraplasty after suboccipital decompression in Chiari 1 patients: a case series. Surg Neurol. Int. 2013;4:6.

Sun X, Sun C, Liu X, Liu Z, Qi Q, Guo Z, et al. The frequency and treatment of dural tears and cerebrospinal fluid leakage in 266 patients with thoracic myelopathy caused by ossification of the ligamentum flavum. Spine. 2012;37(12):E702-7.

Fontaine N, Charpiot A, Debry C, Gentine A. A case of spontaneous intracranial hypotension: from Ménière-like syndrome to cerebral involvement. Eur Ann Otorhinolaryngol Head Neck Dis. 2012;129:153-6.

Cammisa JT Jr, Girardi FP, Sangani PK, Parvataneni HK, Cadag S, Sandhu HS. Incidental durotomy in spine surgery. Spine. 2000;25:2663-7.

Green AL, Arnaud A, Batiller J, Eljamel S, Gauld J, Jones P, et al. A multicentre, prospective, randomized, controlled study to evaluate the use of a fibrin sealant as an adjunct to sutured dural repair. Br J Neurosurg. 2014:1-7.

Hobbs CGL, Darr A, Carlin WV. Management of intra-operative cerebrospinal fluid leak following endoscopic trans-sphenoidal pituitary surgery. J Laryngol Otol. 2011;125(3):311-3.

Esposito F, Angileri FF, Kruse P, Cavallo LM, Solari D, Esposito V, et al. Fibrin sealants in dura sealing: a systematic literature review. PLoS One. 2016;11(4):e0151533.

Yoshimoto T, Sawamura Y, Houkin K, Abe H. Effectiveness of fibrin glue for preventing postoperative extradural fluid leakage. Neurol Med Chir. 1997;37(12):886-90.

Kassam A, Horowitz M, Carrau R, Snyderman C, Welch W, Hirsch B, et al. Use of Tisseel fibrin sealant in neurosurgical procedures: incidence of cerebrospinal fluid leaks and cost-benefit analysis in a retrospective study. Neurosurgery. 2003;52(5):1102-5.

Kivelev J, Göhre F, Niemelä M, Hernesniemi J. Experiences with TachoSilR in microneurosurgery. Acta Neurochir. 2015;157(8):1353-7.

Arlt F, Trantakis C, Krupp W, Renner C, Winkler D, Strauss G, Meixensberger J. Cerebrospinal fluid leak after microsurgical surgery in vestibular schwannomas via retrosigmoidal craniotomy. Neurol Res. 2011;33(9):947-52.

Hutter G, von Felten S, Sailer MH, Schulz M, Mariani L. Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial. J Neurosurg. 2014;121(3):735-44.

Kim KD, Wright NM. Polyethylene glycol hydrogel spinal sealant (DuraSeal spinal sealant) as an adjunct to sutured dural repair in the spine: results of a prospective, multicenter, randomized controlled study. Spine. 2011;36:1906-12.

Osbun JW, Ellenbogen RG, Chesnut RM, Chin LS, Connolly PJ, Cosgrove GR, et al. A multicenter, single-blind, prospective randomized trial to evaluate the safety of a polyethylene glycol hydrogel (Duraseal Dural Sealant System) as a dural sealant in cranial surgery. World Neurosurg. 2012;78(5):498-504.