NCT02612220

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

Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection - A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
OTHER	Conservative hemostasis	Complete hemostasis will be achieved without the use of topical agents

Timeline

• Start date: 2015-12-03
• Primary completion: 2017-09-06
• Completion: 2017-09-06
• First posted: 2015-11-23
• Last updated: 2017-10-20

Locations

1 site across 1 country: Germany