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

NCT02612220 | Completed

• 1 other identifier: VTG-03
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage

Keywords

liver resection

Outcome Measures

Primary Outcomes (1)

• Time-to-complete hemostasis

  3 minutes

Study Arms (2)

Experimental Group

EXPERIMENTAL

Complete hemostasis will be achieved using BioFoam® Surgical Matrix

Procedure: BioFoam® Surgical Matrix

Control Group

ACTIVE COMPARATOR

Complete hemostasis will be achieved without the use of topical agents, using conservative hemostasis

Other: Conservative hemostasis

Interventions

BioFoam® Surgical Matrix PROCEDURE

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.

Experimental Group

Conservative hemostasis OTHER

Complete hemostasis will be achieved without the use of topical agents

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• CryoLife, Inc.: collaborator

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

• Rahbari NN, Birgin E, Sturm D, Schwanebeck U, Weitz J, Reissfelder C. Randomized clinical trial of BioFoam(R) Surgical Matrix to achieve hemostasis after liver resection. HPB (Oxford). 2020 Jul;22(7):987-995. doi: 10.1016/j.hpb.2019.10.1529. Epub 2019 Nov 1.

  PMID: 31680010 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Reißfelder, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 23, 2015
• Study Start: December 3, 2015
• Primary Completion: September 6, 2017
• Study Completion: September 6, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-01

Locations

DE (1)