Clinical Trial: Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery
Brief Summary: A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
Detailed Summary: The time it will take to stop bleeding will be measured and compared between patients who are treated with fibrin sealant 2 to those who are treated with Surgicel®.
Sponsor: Ethicon, Inc.
Current Primary Outcome: Hemostatic success within 10 minutes. [ Time Frame: Intraoperative ]
Original Primary Outcome: Hemostatic success within 10 minutes.
Current Secondary Outcome:
- Absence of bleeding at pre-defined time points within 10 minutes [ Time Frame: Intraoperative ]
- Incidence of treatment failures [ Time Frame: Intraoperative ]
- Incidence of potential bleeding-related complications [ Time Frame: 24 hr prior to discharge, Day 7-14 ]
- Adverse events [ Time Frame: Intraoperative, 24 hr prior to discharge, Day 7-14 ]
Original Secondary Outcome:
- Absence of bleeding at pre-defined time points within 10 minutes
- Incidence of treatment failures
- Incidence of potential bleeding-related complications
- Adverse events
Information By: Ethicon, Inc.
Dates:
Date Received: March 23, 2006
Date Started: February 2006
Date Completion:
Last Updated: January 8, 2009
Last Verified: January 2009
