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

Abstract

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 by 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.