Evaluation of the safety and effectiveness of a sealant hemostatic patch for preventing cerebrospinal fluid leaks in cranial surgery.

Abstract

Background: Cerebrospinal fluid (CSF) leak remains a significant source of morbidity after neurosurgical procedures. The objective is to evaluate the effectiveness and safety of a polyethylene glycol-coated collagen patch (PCC) in different neurosurgical procedures.Methods: A retrospective, single-center cohort study in patients who underwent a cranial neurosurgical procedure. After collecting multiple data variables, patients were divided into two groups depending on the use of PCC as sealant on dural closure following procedures.Results: Data from 230 patients were collected (PCC, 128; control group, 102). Incidence of CSF leakage was significantly lower in the PCC group (p<.001). Complications that were significantly lower in PCC than the control group included surgical infection (p=.022), and hydrocephalus (p=.017), as well as reduced rates of reintervention (p<.001) and shorter hospital stays (p=.028). Factors associated with a higher incidence of CSF leakage included posterior fossa procedures, reinterventions and the need for CSF drainage placement. PCC reduced the risk of suffering CSF leakage in more than 75% (p=.002) once adjusted for age, surgical approach, type of cranial opening, reintervention, CSF drainage, dural substitute and dural defect coverage.Conclusions: Our findings confirm PCC as an effective means of preventing CSF leakage following cranial neurosurgery with fewer associated complications.