New study: Tissuemed® rebuts complexity of dural sealing techniques
We read with interest a recent research paper*, published in January’s Spine publication, from Hokkaido University, Japan. The team presents the findings of an ex vivo study comparing four different techniques to repair dural tears. Efficacy was quantified as burst pressure resistance.
We like to monitor all such publications, because the subject matter discussed is so relevant to Tissuemed’s sealant technology and the applicability of TissuePatchDural™ in the prevention of CSF leaks.
The hard way
The paper concluded that CSF leaks could be contained by performing ‘several cycles’ of a number of different treatments, encompassing four different products, namely fibrin, thrombin, a synthetic sheet (PGS) and fibrin spray.
Notably the authors commented that fibrin spray alone was able to seal defects measuring 0.3mm – achieving a ‘burst pressure before breakdown’ of 28mmHg (the normal physiological range is 7-25mmHg). You might like to re-read that first dimension… 0.3mm, which is not really a hole at all.
Unsurprisingly, fibrin on its own was unable to cover and seal larger (and more clinically relevant) holes, with 2.7 and 5mm diameter defects evaluated. So the team resorted to a hybrid approach, utilising various combinations of liquids and absorbable sheet. Dural sealing was achieved with burst pressures between 54mmHg and 147mmHg.
The easy way
The TissuePatchDural way of sealing the dura mater during surgery involves no liquids, no significant preparation and no doubt less time. In benchtop studies, TissuePatchDural routinely achieves >150mmHg burst pressure when used to close a 3mm hole, this being an industry accepted defect dimension.
The original objective of providing a single, self-adhesive film with higher adherence to tissue surfaces, is fully validated by the efforts that the Hokkaido group needed to undertake with a host of other solutions.
John Goodden, Neurosurgeon from Leeds Teaching Hospitals NHS Trust, commented; “From my experience, TissuePatchDural has proven to be a reliable product that seals the dura well. It is fast and easy to apply and has not needed additional augmentation with other sealant products. It is therefore reliable and cost effective, and can save time in the operating theatre too.”
We conclude by asking why would a neuro or spinal surgeon use low strength fibrin-based products or attempt to combine such products with non-adhesive films – in a process that is both challenging and time consuming – when they can achieve a superior seal, with one easy-to-use product, TissuePatchDural™?
*Reference: Effective Repair of Dural Tear Using Bioabsorbable Sheet with Fibrin Glue
Akira Iwata, Masahiko Takahata, Ken Kadoya, Hideaki Sudo, Terufumi Kokabu, Katsuhisa Yamada, Norimasa Iwasaki, Spine 2017 January 31