Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection (BioFoam)

October 19, 2017 updated by: Technische Universität Dresden

Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection - A Randomized Controlled Trial

The present randomized controlled trial evaluates the efficacy and safety of BioFoam® Surgical Matrix in patients undergoing elective liver resection. In contrast to other topical agents, the surgical adhesive BioFoam® Surgical Matrix may not only accelerate hemostasis but also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of postoperative complications.

The primary objective of this trial is to show that time-to-complete hemostasis can be reduced using BioFoam® Surgical Matrix as compared to the conventional approach.

Study Overview

Detailed Description

Hepatic resection is the primary therapy for various hepatobiliary disorders. Advances in preoperative imaging, surgical technique, and perioperative management have markedly improved outcomes and extended the indications for hepatic resection within the past three decades. However, liver resection remains associated with substantial morbidity and mortality of up to 60% and 10%, respectively. The outcome of patients undergoing hepatic resection is closely linked to the amount of intraoperative blood loss. Hemorrhage from the resection surface contributes significantly to the amount of blood loss. In addition, bile leakage from the resection surface presents a persistent clinical challenge. In fact, bile leakage remains the most frequent complication after hepatic resection with an incidence of 5 - 25%. Various topical agents have so far been suggested to facilitate hemostasis with the ultimate aim to improve perioperative outcome. However, none of these agents has so far gained wide acceptance, possibly due to their impractical method of application. Furthermore, these 'hemostatic agents' have been primarily designed to improve hemostasis and showed no effect on perioperative complications and in particular the incidence of bile leakage.

The present randomized controlled trial evaluates the efficacy and safety of BioFoam® Surgical Matrix in patients undergoing elective liver resection. In contrast to other topical agents, the surgical adhesive BioFoam® Surgical Matrix may not only accelerate hemostasis but also facilitate sealing of bile ducts and thus has the potential to reduce the incidence of postoperative complications.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for elective hepatic resection
  • Age equal or greater than 18 years
  • Informed consent

Exclusion Criteria:

  • Previous treatment with BioFoam® Surgical Matrix
  • Known sensitivity to materials of bovine origin
  • Known sensitivity to glutaraldehyde
  • Abnormal calcium metabolism (e.g. chronic renal failure, hyperparathyreoidism)
  • Minimally invasive procedure planned
  • Impaired mental state or language problems
  • Expected lack of compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Complete hemostasis will be achieved using BioFoam® Surgical Matrix
Complete hemostasis is achieved by direct application of BioFoam® (Cryolife Inc., Kennesaw, GA) to the transection surface area of the liver. In addition, the surgeon may use conventional methods such as argon beam coagulation and warm sponges. If more than one syringe of BioFoam® is required to cover the entire transection surface area, a second syringe maybe used. BioFoam® Surgical Matrix will be used according to the supplier's instructions.
Active Comparator: Control Group
Complete hemostasis will be achieved without the use of topical agents, using conservative hemostasis
Complete hemostasis will be achieved without the use of topical agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time-to-complete hemostasis
Time Frame: 3 minutes
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Christoph Reißfelder, MD, Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2015

Primary Completion (Actual)

September 6, 2017

Study Completion (Actual)

September 6, 2017

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTG-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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