U.S. Study of Fibrocaps in Surgical Hemostasis
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.
Device: Fibrocaps (fibrin sealant)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|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|
- Mean Time to Hemostasis (TTH) [ Time Frame: 0-10 minutes ] [ Designated as safety issue: No ]Time to hemostasis recorded from the first application of study treatment until cessation of bleeding
- Safety [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- Number of Participants Achieving Hemostasis at 5 Minutes [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
- Number of Patients Achieving Hemostasis at 10 Minutes [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Fibrocaps + Gelfoam
After identification of a Target Bleeding Site (TBS), topical Fibrocaps should be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
Device: Fibrocaps (fibrin sealant)
Fibrocaps powder (max dose 1.5g) should be applied directly to the bleeding site or to the Gelfoam and then applied to the bleeding site. Re-application of 1.5 g of Fibrocaps is allowed.
Other Name: Pro-0601
Active Comparator: Gelfoam
Treatment is Gelfoam followed by manual pressure with sterile gauze. If hemostasis is not achieved within 10 minutes of the Start Time,the subject should be considered a treatment failure and the surgeon should implement additional hemostatic measures.
An identified Target Bleeding Site (TBS) should be treated with application of Gelfoam followed by light manual pressure with a sterile gauze.
Other Name: Gelfoam
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.