Tissuemed surgical film improves brain surgery outcomes
9 Nov 2010
A study carried out by neurosurgeons at the University of
Padova has found that a surgical film developed by Leeds based Tissuemed
prevented cerebrospinal fluid leakage following brain surgery.
The clinical study at the University of Padova, Italy, involved
12 patients who all had a high risk of developing Cerebrospinal
Fluid (CSF) leakage post operatively. The study has been published
in the British Journal of Neurosurgery .
CSF leakage through the Dura, the covering over these tissues, is
a recognised complication following brain and spinal surgery, with
consequences such as prolonged patient stay in hospital and risk of
related problems for the patient, such as infection and sometimes
even the need for additional operations.
Tissuemed's product, TissuePatchDural, is a very thin membrane,
best thought of as a sort of self-adhesive ‘clingfilm’ to seal the
tissue against fluid leakage, before eventually being absorbed by
In the study, the surgeons used TissuePatchDural when water-tight
closure of the Dura had not been achieved through traditional
Patients were then followed up over a 5 to 9-month period, where
clinical and neuro-radiological examination showed no evidence of
CSF leak in any patient and no device-related adverse events.
One of the authors, Dr Della Puppa, explains in the paper: “TissuePatchDural
is a sealant, like biological glues, but unlike them it is a large
film able to cover large dural surfaces affected by multiple
defects. Moreover, the application does not take time to be
prepared, as with biological glues. In our current dural defect
management in selected patients the use of TissuePatchDural has
reduced time of repairing and improved final results.”
Dr David Mandley, Tissuemed’s director responsible for clinical
affairs commented, “This independent, surgeon-led study provides an
excellent demonstration of the effectiveness, ease of use and safety
of TissuePatchDural as a Dural sealant.
"I expect this paper to be the first in a series of publications
describing the clinical use of this novel surgical sealant film.
Furthermore, it is very well timed as it is also applicable to
ObexNeuroFilm, an equivalent product that from 1st September is
being distributed exclusively by Medtronic our recently announced
1. Alessandro Della Puppa, Marta Rossetto & Renato Scienza. Use
of a new absorbable sealing film for preventing postoperative
cerebrospinal fluid leaks: remarks on a new approach. British
Journal of Neurosurgery. October 2010, Vol. 24, No. 5, Pages