- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02612220
Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection (BioFoam)
Effectiveness of BioFoam® Surgical Matrix to Improve Hemostasis During Liver Resection - A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saxony
-
Dresden, Saxony, Germany, 01307
- Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
Complete hemostasis will be achieved using 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.
|
Active Comparator: Control Group
Complete hemostasis will be achieved without the use of topical agents, using conservative hemostasis
|
Complete hemostasis will be achieved without the use of topical agents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time-to-complete hemostasis
Time Frame: 3 minutes
|
3 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christoph Reißfelder, MD, Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VTG-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemorrhage
-
Region StockholmRecruitingRetinal Hemorrhage, Bilateral | Retinal Hemorrhage, Left Eye | Retinal Hemorrhage, Right EyeSweden
-
Al Hadi HospitalCompletedDiabetic Vitreous HemorrhageKuwait
-
Massachusetts Eye and Ear InfirmaryCompletedPost-operative HemorrhageUnited States
-
Panhandle Eye Group, LLPRecruitingDiabetic Vitreous HemorrhageMexico
-
Weill Medical College of Cornell UniversityThe Edward Grayson Fund for Retinal ResearchUnknownSubretinal Hemorrhage and Exudative MaculopathyUnited States
-
Tel-Aviv Sourasky Medical CenterIsrael Defense ForcesRecruiting
-
Ain Shams Maternity HospitalUnknownPost Operative HemorrhageEgypt
-
Asan Medical CenterUnknownPost Vitrectomy State | Recurrent Diabetic Vitreous HemorrhageKorea, Republic of
-
Assistance Publique - Hôpitaux de ParisTerminatedHemorrhage; Complicating DeliveryFrance
-
University of Sao PauloUnknownHemorrhage | RecurrentBrazil
Clinical Trials on BioFoam® Surgical Matrix
-
CryoLife, Inc.United States Department of DefenseTerminatedIntraoperative BleedingUnited States
-
Integra LifeSciences CorporationCompletedHernia | Pathological Conditions, Anatomical | Hernia, Abdominal | Hernia, VentralUnited States
-
Miromatrix Medical Inc.CompletedGastroesophageal Reflux | GERD | Hiatal Hernia With Gastroesophageal Reflux DiseaseUnited States
-
Mayo ClinicTerminatedBarretts Esophagus With High Grade Dysplasia | Barrett AdenocarcinomaUnited States
-
MicroPort Orthopedics Inc.Active, not recruiting
-
Novus ScientificCompletedInguinal HerniaSweden
-
Walter Reed National Military Medical CenterUnknown
-
Zhejiang Xingyue Biotechnology Co., Ltd.CompletedDonor Site WoundChina
-
Zhejiang Xingyue Biotechnology Co., Ltd.UnknownInguinal HerniaChina
-
Imbed BiosciencesArizona Burn Center, Maricopa Medical Center (Phoenix, AZ)Not yet recruiting