New Study Compares Dural Sealing Technologies

A new paper, published in the most recent Surgical Neurology International, suggests that surgical sealant company Tissuemed’s TissuePatchDural film is at least as effective as gel-based approaches to adjunctive dural closure following neurosurgery.

Background

The newly published paper, from Italy’s Besta Institute, is a retrospective analysis of 161 patients from a single center. All patients had undergone elective posterior fossa surgery, a neurosurgical procedure that is considered to be at a high risk of cerebrospinal fluid leakage. The paper can be found here.

To aid dural sealing under problematic conditions where watertight closure is desirable (but difficult to achieve), different materials have been used, of which two currently available options are TissuePatchDural and DuraSeal. TissuePatchDural is a self-adhesive film sealant that bonds to the tissue surface, while DuraSeal is a polymerising gel that effectively cures once dispensed onto the operative site.

The source of the patients that made up the study population was those in whom primary watertight closure was deemed not possible. As forms of adjunctive closure, these patients had received either TissuePatchDural or DuraSeal treatment.

Results, while not statistically significant and coming from a retrospective analysis of a relatively small patient group, indicate that overall the sealing modalities were comparable when measuring incidence of post-operative CSF leak. That said, TissuePatchDural outperformed DuraSeal (2.1% vs 12.5% incidence) in patients without pre and post-operative risk factors including corticosteroid use, previous surgery and radiation therapy.

So we’re left with the slightly watery conclusion that these sealing modalities both work, but wondering why they didn’t randomize the groups. Could it be that selection of sealant type was driven by the demands of the closure?

For now, Tissuemed can point to the fact that its clever sealant film is safe and effective and looks like it might shade Covidien’s DuraSeal in these challenging cases.

Company comments

‘Effective dural sealing, particularly for posterior fossa surgery where the risk of CSF leaks is increased, is an important factor in postoperative wound management”, said David Mandley, Tissuemed’s CEO. ”We’re excited to share the findings of this second comparative clinical series where the sealing properties of TissuePatchDural™ have been demonstrated.

Source: Tissuemed Ltd.

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