First comparative clinical study finds the use of Tissuemed’s sealant film, TissuePatchDural, more effective in the prevention of CSF leaks and shortens hospital stay in higher risk procedures.

M Palin

Authored by Mr Phillip van Hille and presented, as a poster by Martin Palin, this was a single centre retrospective comparative study involving 101 patients who underwent elective neurosurgery. Patients undergoing posterior fossa surgery received either TissuePatchDural or Tisseel (Baxter Healthcare), a commonly used fibrinogen sealant, to reinforce standard sutured dural closure and prevent cerebrospinal fluid (CSF) leakage. Literature reports that the incidence of CSF leaks following this type of surgery can be as high as 17.6%.

The use of TissuePatchDural reduced the incidence of CSF leaks compared to patients who were treated with Tisseel. The proportion of Tisseel treated patients who developed a post-operative CSF was 17%, compared to 9% for those treated with TissuePatchDural. All leaks were treated conservatively and no patients treated with TissuePatchDural required readmission or repeat surgery. Whilst one patient from the Tisseel group required further surgery, the type and incidence of post-operative complications were equivalent between the two groups and were acceptable. The average length of hospital stay for patients treated with TissuePatchDural was approximately half that of the Tisseel group.

Dr David Mandley, Tissuemed’s CEO commented; “This is the first published clinical series that benchmarks TissuePatchDural against a liquid sealant commonly used for dural closure. The data demonstrates the efficacy and safety of TissuePatchDural in a series of potentially higher risk procedures. Furthermore, there are strong health economic benefits for using TissuePatchDural, including earlier time to discharge and no re-operative costs. I’m delighted to have such positive clinical data from a leading UK hospital and a world renowned centre in the field of neurosurgery.”

To view this poster, please click here.

For further information on TissuePatchDural please click here.

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