The Randomized Clinical Trial of Surgicel® Absorbable Haemostat Covering the Raw Cut Surface During the Hepatectomy
18 Years
70 Years
Both
Liver Neoplasms
Trial Information
The Randomized Clinical Trial of Surgicel® Absorbable Haemostat Covering the Raw Cut Surface During the Hepatectomy
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 Haemostat as an absorbable hemostat in the hepatic surgical patient population.
Subjects who are undergoing hepatic surgical procedures should be considered for this
investigation. The raw cut surface was covered with Surgicel® absorbable Haemostat or none
but was dried by using fine sutures and an argon beam to achieve complete haemostasis.
Subjects can be pre-screened utilizing standard of care data for the specified
inclusion/exclusion criteria to ensure that they are eligible for treatment in the
investigation. If the subject appears to qualify for the investigation, the subject will
then be asked to give his/her written informed consent. All subjects will be followed
through their hospitalization. Follow-up evaluations will include time to removal of wound
drain, the amount of effusion, length of postoperative hospital stay, and incidence of
postoperative morbidity.
From baseline to the final study exam, data pertaining to the investigational objectives
will be recorded on the appropriate case report forms at the predetermined study intervals.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the size of any subphrenic collection or pleural effusion
Outcome Description:
If large amounts of ascites developed, diuretics were given and the volume of infusion was limited. Before removed grainage tube, all patients were examined by ultrasonography performed by a doctor without knowledge of the study. The size of any subphrenic collection or pleural effusion was recorded. The drainage tube was removed when the leakage per 24 h was less than 50 cm3, the appearance of the secretion had changed from hematic to serous, and no bilious or infectious discharge was present, as determined by observation.
Outcome Time Frame:
up time to the drainage tube removed, an expected average of 1 week
Safety Issue:
Yes
Principal Investigator
Jia Fan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Liver cancer institute, fudan university
Authority:
China: Food and Drug Administration
Study ID:
LCI-125-001
NCT ID:
NCT01436721
Start Date:
August 2011
Completion Date:
December 2011
Related Keywords:
- Liver Neoplasms
- Effectiveness
- Device success
- Hepatectomy
- Neoplasms
- Liver Neoplasms
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