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

Not Applicable

Completed

• Conditions: Hemorrhage
• Interventions: Other: Conservative hemostasis; Procedure: BioFoam® Surgical Matrix

• Registration Number: NCT02612220
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-23
• Study Start: 2015-12-03
• Status Verified: 2017-01
• Primary Completion: 2017-09-06
• Study Completion: 2017-09-06
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Conservative hemostasis	Complete hemostasis will be achieved without the use of topical agents, using conservative hemostasis
Experimental Group	BioFoam® Surgical Matrix	Complete hemostasis will be achieved using BioFoam® Surgical Matrix

Primary Outcome Measures

Name	Time	Method
Time-to-complete hemostasis	3 minutes

Trial Locations

Locations (1)

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