Adhesive Sealant Film Prevents CSF Leaks: New Study

“In our experience the product appears to be safe and no adverse reaction was evident throughout the study. Results in terms of CSF leak prevention are promising.”

Abstract

UK surgical sealant film company Tissuemed Ltd. has announced the publication of a new clinical paper in World Neurosurgery relating to its self-adhesive dural sealant film products. This retrospective analysis of patients undergoing elective neurosurgery at Milan’s Besta Institute suggests that application of this novel, synthetic film over sutured dura provides a safe and effective means of reducing incidence of post-operative Cerebrospinal Fluid(CSF) leakage.

Background

TissuePatch products are thin, synthetic, films which bond covalently to amine groups on the surface of internal tissues to provide a watertight seal. As such these films are used as an adjunct to traditional suturing or stapling in a variety of surgical procedures where achieving a secure closure is paramount. In this case the material was used in its TissuePatchDural form to prevent leakage of CSF from dural closures following neurosurgery.

The study

Authored by Dr Paolo Ferroli, Professor Giovanni Broggi and co-workers at the Carlo Besta Institute, Milan, this is a single centre retrospective study detailing 119 patients who underwent elective neurosurgery. All patients received TissuePatchDural to reinforce dural closure following identification of a CSF leak after routine microsuture closure.

This was a mixed population of patients including 22 assessed as being high risk for reasons including previous surgery, radiotherapy, long term corticosteroid use and hydrocephalus. Supratentorial, Infratentorial and Spinal patients were also included.

Overall results

Overall CSF leaks were detected in 11 of the 119 patients (9.2%), all occurring within two weeks of surgery. Patients were additionally assessed at 2 and 6 months following treatment and none were found to be suffering CSF leakage. All leaks were treated conservatively and no patient required readmission or repeat surgery.

High risk patients

CSF leakage.In the 22 patients considered high risk there was a higher (36.3%) percentage of CSF leaks, compared to a 3.1% leak rate in 97 cases without additional risk.

Clinician comments

The authors commented “In our experience the product appears to be safe and no adverse reaction was evident throughout the study. Results in terms of CSF leak prevention are promising.”

Company comments

Dr David Mandley, Tissuemed’s CEO, commented: “This latest paper, the third in 12 months published by European Neurosurgeons, represents the largest patient cohort receiving TissuePatchDural to be investigated and reported to date. As we approach four years since the launch of TissuePatchDural I’m delighted to have such positive clinical experience and published data from the Carlo Besta Institute, a highly regarded and world renowned centre of excellence in the field of neurosurgery.”

The data also supports use of TissuePatchDural’s sister product ObexNeurofilm™, which is distributed by Medtronic’s Neurosurgical Technologies Division

Source: Tissuemed Ltd

Note: The editor of medlatest is a former Director and CEO of Tissuemed Ltd and retains a financial interest in the company.