Use of an Oxidized Regenerated Cellulose After Hepatic Surgery

Hepatectomy is one of the best treatments for malignant or benign lesions of the liver. The mortality and morbidity rates after hepatectomy have declined in recent years because of the precise measurement of liver functional reserve, a better understanding of liver anatomy, meticulous haemostasis during operation and improved postoperative management. Although surgical techniques have improved, life-threatening complications, such as intra-abdominal bleeding, bile leakage and subphrenic infection, now cannot be completed avoided. The local complications were most associated with the liver section treatment during the operation. Hence, the need for safer and more effective hemostatic treatment than the conventional approaches, such as intraoperative pressure by surgical gauze, ligatures, and electrocoagulation by mono- or bipolar instruments. Surgicel® absorbable Haemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. After Surgicel® has been saturated with blood, it swells into a brownish or black gelatinous mass which aids in the formation of a clot, thereby serving as a haemostatic adjunct in the control of local haemorrhage barriers on section. The present randomized clinical trial was designed to evaluate the efficacy and safety of Surgicel® absorbable Haemostat covering the raw cut surface during the hepatectomy.

Sex

All

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

1. The subject is 18 years to 70 Years
2. The subject is undergoing major hepatectomy (right hemihepatectomy, right posterior sectionectomy, and right anterior sectionectomy) without concomitant operation on another organ or anastomosis between bile ducts, or bile ducts and the digestive tract, and no abdominal infection
3. The subject is willing and able to provide appropriate informed consent
4. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations

Exclusion Criteria:

1. The subject is known or suspected to be pregnant (verified in a manner consistent with institution's standard of care), or is lactating
2. The subject has an active infection at the surgical site
3. The use of hemostatic agents are contraindicated for the subject
4. The subject has a known bleeding disorder (including thrombocytopenia \[\< 100,000 platelet count\], thromboasthenia, hemophilia, or von Willebrand disease)
5. The subject has had surgery at the intended application site ≤ 6 months before the current surgical procedure
6. The subject is unavailable for follow-up
7. The subject is currently participating in another investigational device or drug trial
8. Administration of non-steroidal anti-inflammatory drugs (NSAIDs) or anti-platelet agents within 1 week before surgery