title: 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.
abstract: OBJECTIVE
  Cerebrospinal fluid leakage is an immanent risk of cranial surgery with dural opening. Recognizing the risk factors for this complication and improving the technique of dural closure may reduce the associated morbidity and its surgical burden. The aim of this paper was to investigate whether the addition of TachoSil on top of the dural suture reduces postoperative CSF leakage compared with dural suturing alone and to assess the frequency and risk factors for dural leakage and potentially related complications after elective craniotomy.
  
  
  METHODS
  The authors conducted a prospective, randomized, double-blinded single-center trial in patients undergoing elective craniotomy with dural opening. They compared their standard dural closure by running suture alone (with the use of a dural patch if needed) to the same closure with the addition of TachoSil on top of the suture. The primary end point was the incidence of CSF leakage, defined as CSF collection or any open CSF fistula within 30 days. Secondary end points were the incidence of infection, surgical revision, and length of stay in the intensive care unit (ICU) or intermediate care (IMC) unit. The site of craniotomy, a history of diabetes mellitus, a diagnosis of meningioma, the intraoperative need of a suturable dural substitute, and blood parameters were assessed as potential risk factors for CSF leakage.
  
  
  RESULTS
  The authors enrolled 241 patients, of whom 229 were included in the analysis. Cerebrospinal fluid leakage, mostly self-limiting subgaleal collections, occurred in 13.5% of patients. Invasive treatment was performed in 8 patients (3.5%) (subgaleal puncture in 6, lumbar drainage in 1, and surgical revision in 1 patient). Diabetes mellitus, a higher preoperative level of C-reactive protein (CRP), and the intraoperative need for a dural patch were positively associated with the occurrence of the primary end point (p = 0.014, 0.01, and 0.049, respectively). Cerebrospinal fluid leakage (9.7% vs 17.2%, OR 0.53 [95% CI 0.23-1.15], p = 0.108) and infection (OR 0.18 [95% CI 0.01-1.18], p = 0.077) occurred less frequently in the study group than in the control group. TachoSil significantly reduced the probability of staying in the IMC unit for 1 day or longer (OR 0.53 [95% CI 0.27-0.99], p = 0.048). Postoperative epidural hematoma and empyema occurred in the control group but not in the study group.
  
  
  CONCLUSIONS
  Dural leakage after elective craniotomy/durotomy occurs more frequently in association with diabetes mellitus, elevated preoperative CRP levels, and the intraoperative need of a dural patch. This randomized controlled trial showed no statistically significant reduction of postoperative CSF leakage and surgical site infections upon addition of TachoSil on the dural suture, but there was a significant reduction in the length of stay in the IMC unit. Dural augmentation with TachoSil was safe and not related to adverse events. Clinical trial registration no. NCT00999999 ( http://www.ClinicalTrials.gov ).
authors.affiliation: Neurosurgical Department and.
authors.forename: Gregor
authors.initials: G
authors.lastname: Hutter
authors.forename: Stefanie
authors.initials: S
authors.lastname: von Felten
authors.forename: Martin H
authors.initials: MH
authors.lastname: Sailer
authors.forename: Marianne
authors.initials: M
authors.lastname: Schulz
authors.forename: Luigi
authors.initials: L
authors.lastname: Mariani
mesh_terms: D000328:Adult; D000368:Aged; D002097:C-Reactive Protein / Q000378:metabolism; D065634:Cerebrospinal Fluid Leak; D002559:Cerebrospinal Fluid Rhinorrhea / Q000453:epidemiology* / Q000517:prevention & control*; D003399:Craniotomy / Q000009:adverse effects* / Q000379:methods; D048909:Diabetes Complications / Q000150:complications; D004311:Double-Blind Method; D004338:Drug Combinations; D004388:Dura Mater / Q000601:surgery*; D017558:Elective Surgical Procedures / Q000009:adverse effects*; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011184:Postoperative Period; D011446:Prospective Studies; D012086:Reoperation; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000453:epidemiology; D013536:Suture Techniques; D013917:Thrombin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C518955:TachoSil; D005340:Fibrinogen; D002097:C-Reactive Protein; D013917:Thrombin
keywords: CRP = C-reactive protein; GLM = generalized linear model; ICU = intensive care unit; IMC = intermediate care; cerebrospinal fluid leakage; dural sealant; surgical quality; surgical site infection; surgical technique