Status:
UNKNOWN
Use of an Oxidized Regenerated Cellulose After Hepatic Surgery
Lead Sponsor:
Fudan University
Conditions:
Liver Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
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 measure...
Detailed Description
This is a prospective, randomized, single-center investigation with a minimum of forty (40) controlled study subjects designed to evaluate the safety and effectiveness of the Surgicel® absorbable Haem...
Eligibility Criteria
Inclusion
- The subject is 18 years to 70 Years
- 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
- The subject is willing and able to provide appropriate informed consent
- The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations
Exclusion
- The subject is known or suspected to be pregnant (verified in a manner consistent with institution's standard of care), or is lactating
- The subject has an active infection at the surgical site
- The use of hemostatic agents are contraindicated for the subject
- The subject has a known bleeding disorder (including thrombocytopenia \[\< 100,000 platelet count\], thromboasthenia, hemophilia, or von Willebrand disease)
- The subject has had surgery at the intended application site ≤ 6 months before the current surgical procedure
- The subject is unavailable for follow-up
- The subject is currently participating in another investigational device or drug trial
- Administration of non-steroidal anti-inflammatory drugs (NSAIDs) or anti-platelet agents within 1 week before surgery
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01436721
Start Date
August 1 2011
End Date
December 1 2011
Last Update
September 20 2011
Active Locations (1)
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1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032