Hepatectomy Clinical Trial
Official title:
Exploratory Phase IV Randomized Single Blind Study Evaluating the Efficacy and Tolerability of Hemopatch in Improving Time of Hemostasis and Preventing Post-operative Complications After Hepatic Resection
- 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.
Advances in surgical techniques have reduced the occurrence of postoperative complications
following liver resection and resulted in low surgical mortality and morbidity rates in
high-volume centers.
Although partial liver resections for primary or secondary hepatic malignancies are
considered standard interventions, intraoperative blood loss remains a risk factor associated
with major complications in liver surgery [1-3]. There are several methods for reduction of
blood loss, including meticulous resection technique along anatomical planes, reduction of
central venous pressure during transection of the liver parenchyma [4], and vascular
occlusion techniques (i.e., inflow occlusion and total vascular occlusion) [5-7]. In
addition, specific instruments were devised for liver transection, such as the ultrasonic
dissector, water jet, and other, more recent developments (e.g., focal radiofrequency
ablation) that allow sealing of small vessels during transection [8, 9].
In order to control diffuse bleeding and to prevent intraperitoneal complications attributed
to bleeding, various topical products are used when the conventional methods, such as suture,
ligation, or argon beam coagulation, fail. Currently, there are numerous products on the
market which are promising a successful outcome for hemostasis. These products include
gelatin, collagen, oxidized regenerated cellulose, fibrin sealant glues, and synthetic glues.
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