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

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ClinicalTrials.gov Identifier: NCT02612220
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
CryoLife, Inc.
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hemorrhage Procedure: BioFoam® Surgical Matrix Other: Conservative hemostasis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection - A Randomized Controlled Trial
Actual Study Start Date : December 3, 2015
Actual Primary Completion Date : September 6, 2017
Actual Study Completion Date : September 6, 2017

Arm Intervention/treatment
Experimental: Experimental Group
Complete hemostasis will be achieved using BioFoam® Surgical Matrix
Procedure: 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
Other: Conservative hemostasis
Complete hemostasis will be achieved without the use of topical agents




Primary Outcome Measures :
  1. Time-to-complete hemostasis [ Time Frame: 3 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612220


Locations
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Germany
Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
CryoLife, Inc.
Investigators
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Principal Investigator: Christoph Reißfelder, MD Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02612220    
Other Study ID Numbers: VTG-03
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: January 2017
Keywords provided by Technische Universität Dresden:
liver resection
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Hemostatics
Coagulants