Clinical Trial: U.S. Study of Fibrocaps in Surgical Hemostasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A U.S. Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocaps™ and Gelatin Sponge (USP) in Surgical Hemostasis

Brief Summary: The purpose of this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or impractical.

Detailed Summary:

This was a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 90 subjects undergoing spinal surgery, hepatic resection, specific soft tissue dissection, or peripheral vascular surgery, ((including peripheral artery bypass and arteriovenous graft formation for hemodialysis using either Polytetrafluoroethylene (PTFE) or native grafts)). Subjects were randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.

Use of the Fibrospray device was optional for spinal and vascular surgeries, but required for the general surgery procedures. All investigators using the Fibrospray device were trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.


Sponsor: Mallinckrodt

Current Primary Outcome: Mean Time to Hemostasis (TTH) [ Time Frame: 0-10 minutes ]

Time to hemostasis recorded from the first application of study treatment until cessation of bleeding


Original Primary Outcome: Time to hemostasis of Fibrocaps plus gelatin sponge (USP), as compared to gelatin sponge (USP) alone [ Time Frame: 0-10 minutes ]

Time to hemostasis recorded from time 0 until cessation of bleeding


Current Secondary Outcome:

  • Safety [ Time Frame: 28 Days ]
    Number of participants with Adverse events and clinically-significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the TBS
  • Number of Subjects Achieving Hemostasis at 3 Minutes [ Time Frame: 3 minutes ]
  • Number of Participants Achieving Hemostasis at 5 Minutes [ Time Frame: 5 minutes ]
  • Number of Patients Achieving Hemostasis at 10 Minutes [ Time Frame: 10 minutes ]


Original Secondary Outcome:

  • Safety [ Time Frame: 28 Days ]
    Adverse events and clinically-significant changes/findings on labs and physical examination
  • Proportion of subjects achieving hemostasis within each group at 3, 5, and 10 minutes. [ Time Frame: 3, 5, and 10 minutes ]


Information By: Mallinckrodt

Dates:
Date Received: December 6, 2010
Date Started: December 2010
Date Completion:
Last Updated: July 22, 2016
Last Verified: July 2016