Clinical Trial: A Study of Fibrocaps in Liver Surgery in the Netherlands

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

Official Title: A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge in Surgical Hemostasis in the Netherlands

Brief Summary: A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.

Detailed Summary:

This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery.

The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. All investigators using the Fibrospray device will be 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: Time to Hemostasis [ Time Frame: 0-10 minutes ]

Time from application of treatment to cessation of bleeding


Original Primary Outcome: Same as current

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 target bleeding site (TBS)
  • Incidence of Hemostasis at 5 Minutes [ Time Frame: 5 minutes ]
    Number of subjects in each group that achieved hemostasis at pre-specified times after treatment
  • Number of Subjects Achieving Hemostasis at 3 Minutes [ Time Frame: 3 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 on laboratory or physical exam


Information By: Mallinckrodt

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