Safety and effectiveness of Evicel* for sutured dural repair

• Research type

  Research Study

• Full title

  A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL* as an Adjunct to Sutured Dural Repair

• IRAS ID

  38605

• Contact name

  Alexander Green

• Sponsor organisation

  Omrix Biopharmaceuticals Ltd

• Eudract number

  2009-016501-41

• ISRCTN Number

  n/a

• Research summary

  A study investigating the use of Evicel to prevent cerebrospinaflud (CSF) leakage following neurosurgery. If the surgeon observes CSF leakage after suturing the dura, the patient will be randomised to Evicel or further suturing.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  10/H0604/12

• Date of REC Opinion

  30 Mar 2010

• REC opinion

  Further Information Favourable Opinion