| Home | E-Submission | Sitemap | Contact Us |  
top_img
The Nerve > Volume 2(2); 2016 > Article
Ha, Cheong, and Yi: Risk Factors for Cerebrospinal Fluid Leakage after Craniotomy and the Efficacy of Dural Sealants Application versus Dural Suturing Alone

Abstract

Objective

Cerebrospinal fluid (CSF) leakage is a latent risk of cranial surgery with dural opening. We hypothesize that addition of Duraform on top of dural suture reduces postoperative CSF leakage in cranial surgery with dural opening. The aim of this study was to assess the efficacy of dural sealants application against dural suturing alone and risk factors for CSF leakage and potentially related complications after craniotomy.

Methods

A retrospective review of patients undergoing craniotomy with dural opening over a 3-year period at a single institution was performed. We compared our standard dural closure by continuous running suture alone to the same closure with the addition of Duraform on top of the suture. Logistic regression analyses were performed to determine the variables associated with CSF leakage and infection.

Results

Three hundred sixty-three patients were included with mean follow-up of 13±standard deviation (SD) of 9.2 months in the study group (n=117) and 18±11.2 months in the control group (n=246). Postoperative CSF leaks were identified in 6 patients (5.1%) in the Duraform application group and in 31 (12.6%) in the control group. Multivariate logistic regression modeling identified diabetes mellitus and infratentorial operative location as significant predictors of CSF leak.

Conclusion

This study shows that addition of dural sealant upon the dural suture reduces postoperative CSF leak and infection after elective craniotomy. Its clinical use for dural augmentation was safe and not related to adverse events. Diabetes mellitus and infratentorial operative location were identified as risk factors for postcraniotomy CSF leak.

INTRODUCTION

It is common practice to reapproximate the dura to prevent the leakage of cerebrospinal fluid (CSF) at the end of craniotomy procedures. Dural closure occurs by reapproximation of the dural edges with suture or by inserting a graft material between the dural defect. CSF leakage is a latent risk of cranial surgery with dural opening. According to the literature, CSF leaks vary from 4% in transsphenoidal procedures to 32% in posterior fossa procedures8). Recognizing the risk factors for this complication and improving the technique of dural closure may reduce the associated morbidity and its surgical burden.
Numerous techniques and materials have been described for dural closure. Most techniques utilize autologous tissue grafts of fat, muscle or pericranium, with or without the use of postoperative lumbar CSF drainage15,17). Various adhesive substances for duraplasty are currently in use, including collagen matrix and fibrin glue10,11). However, dural closure with synthetic grafts has been suggested to contribute to the occurence of infection and CSF leak9,14). Therefore, surgeon should decide whether to use synthetic dural substitute in conflict between the potential benefit of improved dural closure with the potential increase in infection rate.
We have used Duraform as the final layer of dural closure in elective craniotomy since 2013. The purpose of this study was to evaluate the usefulness of Duraform(Codman & Shurtleff Inc., Raynham, MA, USA) as dural sealant based on the authors’ experience over the past 3 years. We compared our standard dural closure by continuous suture alone to the same closure with the addition of Duraform on top of the suture. Furthermore, we assessed the risk factors for CSF leakage and potentially related complications after craniotomy.

MATERIALS AND METHODS

1. Patients and Inclusion/Exclusion Criteria

A consecutive retrospective study was established of patients undergoing elective craniotomy between March 2012 and February 2015 at a single institution (Hanyang University Medical Center). Between 2012 and 2013, 246 patients underwent elective craniotomy with standard dural closure by continuous suture, with or without use of dural patch. Dural augmentation with Duraform technique was first used in 117 consecutive patients commencing in March 2014. The medical records and operative notes were reviewed to identify procedure-related complications. Preoperative inclusion criteria consisted of supra- or infratentorial surgery that required a dural incision and age 18 years or older. Exclusion criteria were burr hole placement alone, previous surgery at the same site, transnasal transsphenoidal surgery, and the presence of temporary CSF diversion. Additionally, trauma patients and those who underwent an operation for infectious lesions were excluded.

2. Surgical Technique

All patients underwent a craniotomy with dural closure with continuous, resorbable synthetic monofilament 4-0 suture to obtain a watertight closure. In case of an obvious dural defect with CSF leakage impeding primary suturing, a dural patch (Duragen, Integra Neuroscience, Plainsboro, NJ, USA) was sutured to the dura mater, aiming at a watertight closure in both groups. There was no difference in usage of dural patch materials between control and study groups. The size of dural patch was determined by the diameter of dural defect. In the Duraform application group, dried fleece was cut to size then moistened and applied on top of the entire dural suture. The bone flap was fixed using titanium screws and plates. The scalp was closed in 2 layers (galeal/subcutaneous and cutaneous).

3. Outcomes

Complications from the operation were recorded as either no complication, developing an infection based on Centers for Disease Control and Prevention standards for surgical site infection4), or developing a CSF leak based on a grading scheme to assess CSF collection5). Each patient was clinically assessed on postoperative days 5 to 7 for occurrence of any CSF collection. Each CSF collection was measured clinically and with computed tomography images.

4. Statistical Analysis

Statistical analysis was performed using SPSS version 22 (SPSS Inc., Chicago, IL, USA). Logistic regression analyses were performed to determine the variables associated with CSF leakage and infection. A p-value of less than 0.05 was considered significant.

RESULTS

Three hundred sixty-three patients were included with mean follow-up of 13±standard deviation (SD) of 9.2 months in the study group (n=117) and 18±11.2 months in the control group (n=246). Patient demographic and clinical characteristics are shown in Table 1. There were no statistically significant differences between groups.
As shown in Table 2, postoperative CSF leaks were identified in 6 patients (5.1%) in the Duraform application group and in 31 (12.6%) in the control group. In the study group, only two (1.7%) patients developed meningitis, and no other complications were reported during the follow-up period. However, in the control group, 19 patients (7.7%) developed meningitis during the postoperative period. The mean postoperative hospital stay was quite shorter in the study group (9.1±1.3 days) than in the control group (12.6±2.8 days).
Univariate logistic regression analysis identified diabetes mellitus, use of dural patch, and infratentorial operative location as having a significant association with postoperative CSF leak. Similarly, univariate predictors of CSF leak were found to be diabetes mellitus, length of operation, estimated blood loss, and infratentorial operative location (Table 3).
Multivariate logistic regression modeling identified infratentorial operative location (odds ratio [OR] 4.68, 95% confidence interval [CI] 1.34-15.98; p=0.019) as significant predictors of CSF leak (Table 4). No factors found to be predictor of infection in multivariate analysis (Table 5).

DISCUSSION

The result of our study indicates that the addition of Duraform on top of the dural suture during elective craniotomy can be useful in preventing CSF leak after cranial surgery and obviates the need for interventions due to CSF collection, which can shorten the length of hospital stay. Several studies have described the use of sealants as helpful in preventing CSF leakage in supratentorial1,13), infratentorial3), skull base12), and spinal6,8) surgeries which consistent with our study. However, instead of getting the benefit of improved dural closure, the surgeons are faced with the potential increase in infection associated with the implantation of an artificial material5). Any foreign material implanted into the body stimulates a host response such as inflammatory cell infiltration or neovascularization2,7). In contrary to prior reports, we observed a lower frequency of serious complications, such as meningitis and epidural empyema, in the Duraform application group. Hutter et al.5) suggested a theory for explanation of this finding that optimal sealing of the intradural compartment by dural augmentation avoids bacterial migration through microlesions even by the dural suture itself. Furthermore, our analysis suggests that patient-centered variables are more influential in the development of infection than the selection of dural substitute materials or dural repair techniques.
Among the factors examined, infratentorial craniotomy was found to be associated with postoperative CSF leak. Infratentorial surgery predisposes a patient to CSF leak because the hydrostatic pressure of the fluid column puts additional stress on the dural suture16). The association between CSF leak and diabetes mellitus has so far rarely been identified in the current literature. Possible explanation for this finding might be that diabetes mellitus impairs wound healing resulting in failure of dural closure.
Several limitations of the present study include its retrospective nature, single center experience, and its relatively small cohort. Additionally, the results are not generalizable at different institutions due to different patient management protocols. Further studies encompassing a larger cohort of patients need to be established.

CONCLUSION

The present study shows that addition of dural sealant upon the dural suture reduces postoperative CSF leak and surgical site infection after elective craniotomy with dural opening. Its clinical use for dural augmentation was safe and not related to adverse events. Furthermore, clinical risk factors exist for postcraniotomy CSF leak and infection: diabetes mellitus and infratentorial operative location.

Table 1
Patient characteristics
Study group (n=117) Control group (n=246) p-value
Sex (female, n) 66 (56.4%) 151 (61.4%) 0.26
Mean age (years) 56.6±15.2 57.0±16.6 0.67
Mean BMI (kg/m2) 23.2±1.7 23.0±1.2 0.77
Active cigarette smoker 24 (20.5%) 52 (21.1%) 0.49
Diabetes mellitus 11 (9.4%) 22 (8.9%) 0.65
Indication for surgery 0.72
 Tumor 48 (41.0%) 118 (48.0%)
 Aneurysm 55 (47.0%) 104 (42.3%)
 ICH 8 (6.8%) 14(5.7%)
 A-V malformation 1 (0.9%) 2 (0.8%)
 Microvascular decompression 5 (4.3%) 8 (3.3%)
Operative procedure 0.81
 Craniotomy 104 (88.9%) 215 (87.4%)
 Craniectomy 13 (11.1%) 31 (12.6%)
Location of craniotomy 0.36
 Supratentorial 98 (83.8%) 203 (82.5%)
 Infratentorial 19 (16.2%) 43 (17.5%)
Use of dural patch 39 (33.3%) 77 (31.3%) 0.87
Mean length of operation (min) 242.6±11.2 228.3±10.4 0.47
Mean EBL (mL) 355.5±19.4 348.5±18.2 0.79
Mean craniotomy diameter (cm) 7.1±2.8 6.8±2.6 0.19

BMI: body mass index; ICH: intracerebral hematoma; A-V: arteriovenous; EBL: estimated blood loss; min: minutes.

Table 2
Complications related with craniotomy according to dural closure method
Surgical variable Study group (n=117) Control group (n=246) p-value
Postoperative CSF leak 6 (5.1%) 31 (12.6%) 0.041
Meningitis 2 (1.7%) 19 (7.7%) 0.023
Epidural empyema 1 (0.9%) 6 (2.4%) 0.248
Length of hospital stay (days) 9.1±1.3 12.6±2.8 0.067

CSF: cerebrospinal fluid.

Table 3
Univariate logistic regression analysis of variables suspected to be related to cerebrospinal fluid leak and infection
Predictor CSF leak (p-value) Infection (p-value)
Age 0.833 0.213
BMI 0.350 0.143
Active cigarette smoker 0.484 0.204
Diabetes mellitus 0.021 0.041
Use of dural patch 0.035 0.173
Length of operation 0.114 0.026
EBL 0.478 0.024
Infratentorial operative location 0.009 0.048
Craniotomy diameter 0.271 0.318

CSF: cerebrospinal fluid; BMI: body mass index; EBL: estimated blood loss.

Table 4
Multivariate logistic regression analysis of factors related to cerebrospinal fluid leak
Factor OR (95% CI) p-value
Diabetes mellitus 1.82 (0.33-9.35) 0.448
Use of dural patch 3.26 (0.98-1.82) 0.196
Length of operation 1.01 (0.99-1.05) 0.523
Infratentorial operative location 4.68 (1.34-15.98) 0.019

OR: odds ratio; CI: confidence interval.

Table 5
Multivariate logistic regression analysis of factors related to infection
Factor OR (95% CI) p-value
Diabetes mellitus 3.41 (0.73-13.64) 0.113
Length of operation 1.02 (0.93-1.08) 0.682
EBL 1.01 (0.99-1.02) 0.627
Infratentorial operative location 2.72 (0.42-14.06) 0.263

OR: odds ratio; CI: confidence interval; EBL: estimated blood loss.

REFERENCES

1. Boogaarts JD, Grotenhuis JA, Bartels RH, Beems T: Use of a novel absorbable hydrogel for augmentation of dural repair: results of a preliminary clinical study. Neurosurgery 57:146-151, 2005
crossref pmid
2. Cole PD, Stal D, Sharabi SE, Hicks J, Hollier LH Jr: A comparative, long-term assessment of four soft tissue substitutes. Aesthet Surg J 31:674-681, 2011
crossref pmid
3. Grotenhuis JA: Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases. Surg Neurol 64:490-493, 2005
crossref pmid
4. Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG: CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol 13:606-608, 1992
crossref pmid
5. 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 121:735-744, 2014
crossref pmid
6. Jankowitz BT, Atteberry DS, Gerszten PC, Karausky P, Cheng BC, Faught R, et al: Effect of fibrin glue on the prevention of persistent cerebral spinal fluid leakage after incidental durotomy during lumbar spinal surgery. Eur Spine J 18:1169-1174, 2009
crossref pmid pmc
7. Khorasani L, Kapur RP, Lee C, Avellino AM: Histological analysis of DuraGen in a human subject: case report. Clin Neuropathol 27:361-364, 2008
crossref pmid
8. Kumar A, Maartens NF, Kaye AH: Evaluation of the use of Bio Glue in neurosurgical procedures. J Clin Neurosci 10:661-664, 2003
crossref pmid
9. Malliti M, Page P, Gury C, Chomette E, Nataf F, Roux FX: Comparison of deep wound infection rates using a synthetic dural substitute (neuro-patch) or pericranium graft for dural closure: a clinical review of 1 year. Neurosurgery 54:599-603, 2004
crossref pmid
10. Narotam PK, Qiao F, Nathoo N: Collagen matrix duraplasty for posterior fossa surgery: evaluation of surgical technique in 52 adult patients. Clinical article J Neurosurg 111:380-386, 2009
crossref pmid
11. Narotam PK, Reddy K, Fewer D, Qiao F, Nathoo N: Collagen matrix duraplasty for cranial and spinal surgery: a clinical and imaging study. J Neurosurg 106:45-51, 2007
crossref pmid
12. Nistor RF, Chiari FM, Maier H, Hehl K: The fixed combination of collagen with components of fibrin adhesive-a new hemostypic agent in skull base procedures. Skull Base Surg 7:23-30, 1997
crossref pmid pmc
13. Reddy M, Schoggl A, Reddy B, Saringer W, Weigel G, Matula C: A clinical study of a fibrinogen-based collagen fleece for dural repair in neurosurgery. Acta Neurochir (Wien) 144:265-269, 2002
crossref pmid
14. Stendel R, Danne M, Fiss I, Klein I, Schilling A, Hammersen S, et al: Efficacy and safety of a collagen matrix for cranial and spinal dural reconstruction using different fixation techniques. J Neurosurg 109:215-221, 2008
crossref pmid
15. Vanaclocha V, Saiz-Sapena N: Duraplasty with freeze-dried cadaveric dura versus occipital pericranium for Chiari type I malformation: comparative study. Acta Neurochir (Wien) 139:112-119, 1997
crossref pmid
16. Walcott BP, Neal JB, Sheth SA, Kahle KT, Eskandar EN, Coumans JV, et al: The incidence of complications in elective cranial neurosurgery associated with dural closure material. J Neurosurg 120:278-284, 2014
crossref pmid
17. Zaidi HA, Pendleton C, Cohen-Gadol AA, Quinones-Hinojosa A: Harvey Cushing’s repair of a dural defect after a traumatic brain injury: novel use of a fat graft. World Neurosurg 75:696-699, 2011
crossref pmid
Editorial Office
Department of Neurosurgery, Seoul St. Mary's Hospital, The Catholic University of Korea
222 Banpodae-ro, Seocho-gu, Seoul 06591, Republic of Korea
TEL: +82-2-2258-6122   FAX: +82-2-594-4248   E-mail: Nerve.KPNS@gmail.com
About |  Browse Articles |  Current Issue |  For Authors and Reviewers
Copyright © The Korean Society of Peripheral Nervous System. All rights reserved.                 Developed in M2Community