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

NCT ID: NCT02612220

Last Updated: 2017-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-03
• Study Completion Date: 2017-09-06

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.

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.

Conditions

Hemorrhage

Keywords

liver resection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

Complete hemostasis will be achieved using BioFoam® Surgical Matrix

Group Type: EXPERIMENTAL

BioFoam® Surgical Matrix

Intervention Type: 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.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Conservative hemostasis

Intervention Type: OTHER

Complete hemostasis will be achieved without the use of topical agents

Interventions

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.

Intervention Type: PROCEDURE

Conservative hemostasis

Complete hemostasis will be achieved without the use of topical agents

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CryoLife, Inc.

INDUSTRY

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Reißfelder, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Dresden, Saxony, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 31680010 (View on PubMed)

Other Identifiers

VTG-03

Identifier Type: -

Identifier Source: org_study_id