NCT01256190

A Study of Fibrocaps in Liver Surgery in the Netherlands

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Postoperative Hemorrhage

Interventions

Type	Name	Description
BIOLOGICAL	Fibrocaps (fibrin sealant)	human thrombin and fibrinogen topical powder
DEVICE	Gelatin sponge	absorbable gelatin sponge for topical use

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2010-12-08
• Last updated: 2016-08-22
• Results posted: 2014-05-15

Locations

1 site across 1 country: Netherlands