Clinical trial NCT02612220: Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection
Official title: Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Keywords: liver resection
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: CryoLife, Inc.
First posted: 2015-11-23
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time-to-complete hemostasis
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
state: Saxony
Study officials:
affiliation: Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
name: Christoph Reißfelder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.