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 the body.
In the study, the surgeons used TissuePatchDural when water-tight closure of the Dura had not been achieved through traditional closure means.
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 distributing partner.”
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 609-611 (doi:10.3109/02688697.2010.500413)