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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the size of any subphrenic collection or pleural effusion
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.
up time to the drainage tube removed, an expected average of 1 week
Jia Fan, MD
Liver cancer institute, fudan university
China: Food and Drug Administration