South Tees Hospitals NHS Foundation Trust has recruited the first two patients in the world for a major commercial research trial.
The world-wide study aims to compare the safety and effectiveness of two different sealants that are used in neurosurgery. Comparison of the two products and analysis of their use in helping to reduce the incidence of cerebrospinal fluid (CSF) leakage could be beneficial for future patient care.
CSF leakage occurs when the fluid around the brain (called cerebral spinal fluid) leaks through a hole in the skull bone. This fluid can either drain from the ear or the nose, depending on where the skull bone is damaged.
CSF leakage is one of the most challenging complications in neurosurgery and can potentially impact on a patient’s outcome following their operation. Therefore further data on which sealant best minimises this risk would be worthwhile.
Initially, Mr Manjunath Prasad, consultant neurosurgeon at South Tees, expressed his interest in supporting this world-wide trial. Once the trust was selected to take part, Mr Prasad worked closely with colleagues from the research and development department, theatres and the neurosurgery directorate to set up the trial.
Emanuel Cirstea, research nurse, agreed to support the trial and coordinate the set-up process, while 11 clinical colleagues (consultant surgeons Anil Varma, Phil Kane, Simon Tizzard, Nitin Mukerji, Pratipal Singh Kalsi, Jonathan Pesic-Smith, Shahid Ahmad Khan, Anna Solth, Georgios Stamatopoulos, Ian Coulter and Tapas Chatterjee) agreed to help identify patients who may be interested in taking part.
Professor Andrew Owens, research and development director at South Tees, said: “I am delighted that we were able to support our clinicians and industry partners in setting up this trial at South Tees and making it available to our patients.
“Achieving this global first is a reflection of the enthusiasm of both our patients and staff for clinical research, and we hope to further build on this success across our specialties.”
Mr Prasad added: “This successful coordination of tasks and regular communication enabled the trust to rapidly obtain the ‘green light’ to start inviting patients to the research.
“The first two patients in the trial were enrolled at The James Cook University Hospital, ahead of other participating hospitals in Europe, Asia-Pacific and the United States – a fantastic outcome for the team, the trust and our region.
“Congratulations to the research team for their efforts in bringing this trial to local patients.”