Clinical Trial: Efficacy and Safety of FS VH S/D 500 S-apr as an Adjunct to Sutured Dural Repair in Cranial Surgery
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated (FS VH S/D 500 S-apr) Compared to DuraSeal Dural Sealant as an Adjunct to
Brief Summary: The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.
Detailed Summary:
Sponsor: Baxter Healthcare Corporation
Current Primary Outcome: Proportion of subjects that do not have a CSF leak intra-operatively and up to the 30-day post-operative period [ Time Frame: Up to 30 days post-operative ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of intra-operative CSF leakage following final Valsalva manoeuver [ Time Frame: Intraoperatively ]
- Incidence of CSF leaks [ Time Frame: Up to 30 days post-operative ]
- Incidence of CSF leaks [ Time Frame: Up to 60 days post-operative ]
- Incidence of AEs [ Time Frame: Up to 60 days post-operative ]
- Incidence of surgical site infections (SSIs) according to US NHSN [ Time Frame: Up to 30 days post-operative ]
Original Secondary Outcome: Same as current
Information By: Baxter Healthcare Corporation
Dates:
Date Received: September 1, 2016
Date Started: September 2016
Date Completion: December 2018
Last Updated: May 5, 2017
Last Verified: May 2017
