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 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.

KEYWORDS:

• Cerebrospinal fluid leakage
• cranial surgery
• dural repair
• dural sealant
• sealant hemostatic patch
• watertight dural closure

Acknowledgments

José Miguel Arbones provided statistical analysis and Antonio Martínez (Ciencia y Deporte S.L., Spain), and Dr Tim Hardman (Niche Science and Technology, United Kingdom) provided writing and editorial assistance, which were funded by Baxter S.L., Spain.

Declaration of interest

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this manuscript.

Reviewer disclosures

Peer reviewers in this manuscript have no relevant financial or other relationships to disclose.

Details of previous presentation

The data in this manuscript have not been published previously either in whole or in part and have not been submitted elsewhere for review. Some of the data were presented in poster format at the 22^nd Conference of the Spanish Neurosurgical Society (SENEC), Toledo, Spain, May 16–18th, 2018.

Additional information

Funding

Baxter S.L. (Spain) facilitated the preparation of this manuscript by providing independent statistical analysis and medical writer services.