Efficacy and Tolerability of Hemopatch After Hepatic Resection

Summary

* Previous in vitro and in vivo studies detected the Hemopatch Sealing Hemostat® to be a new versatile, self-adhering hemostatic sealing pad consisting of a polyethylene glycol-coated collagen.
* Initial study assessed that Hemopatch Sealing Hemostat® can be applied to seal almost any bleeding surface encountered during a range of procedures. The Authors shown that the device is eminently capable in both via laparotomy and laparoscopic approaches, and in patients with impaired coagulation or highly variable anatomies. They support the ease-of-use, application, and immediate hemostatic effect of the patch across a broad range of surgical settings and clinical applications, including solid organ, gastrointestinal, biliopancreatic, endocrine, cardiovascular, and urologic surgeries.
* In a recent published case report the authors reported the feasibility in using Hemopatch Sealing Hemostat® for the management of a myocardial wound, performing the procedure on cardiopulmonary bypass, which meant the patient had to be heparinized. Despite these major risk factors for bleeding Hemopatch Sealing Hemostat® managed to contain bleeding and seal the wound without needing any suture.

These initial results lead up to future randomized clinical trials with more extensive follow-up to assess which is the real contribution of Hemopatch Sealing Hemostat to reduce postoperative bleeding complications in cases where mechanical or energy-driven hemostasis is not possible or insufficient.

Conditions

• Hepatectomy
• Cancer, Metastatic
• Hemostasis

Interventions

DEVICE

Hemopatch

Hemopatch is applied upon the verification made by the surgeon of the presence of an appropriate target bleeding site in the hepatic parenchyma. At the time point of application a stopwatch starts simultaneously. Time to hemostasis is defined as the time required to obtain successful haemostasis in a single bleeding site. At 3 minutes the inspection will be made and, if haemostasis is not achieved, the treatment is considered failed and the Principal Investigator and/or his delegates is allowed to use additional haemostatic measures.The time to haemostasis will be recorded in the patient's medical record and in the electronic Case Report Form. The bleeding site will be observed for 1 additional minute at the end of the haemostatic procedure and, of the surgery to confirm the haemostasis.

PROCEDURE

Common Surgical Techniques

Patients undergoing liver resection for any underlying disease and with resectable mass. The list of the underlying diseases is the following (but might not be limited to): Hepatocellular carcinoma, Hilar cholangiocarcinoma, Adrenal cancer metastasis, Breast cancer metastasis, Colorectal cancer metastasis, Ovarian cancer metastasis, Biliary carcinoma, Hemangioma, Hepatic adenoma, Focal nodular hyperplasia, Unilocular hydatid cyst, Multilocular, hydatid cyst.

Sponsors & Collaborators

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Principal Investigators

• Fabio FP Pacelli, MD · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-17

Primary Completion

2018-11-17

Completion

2019-03-17

Countries

• Italy

Study Locations