Use of an Oxidized Regenerated Cellulose After Hepatic Surgery
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Randomized Clinical Trial of Surgicel® Absorbable Haemostat Covering the Raw Cut Surface During the Hepatectomy|
- the size of any subphrenic collection or pleural effusion [ Time Frame: up time to the drainage tube removed, an expected average of 1 week ] [ Designated as safety issue: Yes ]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.
- time to removal of wound drain [ Time Frame: up time to removal of wound drain, an expected average of 1 week ] [ Designated as safety issue: Yes ]
- length of postoperative hospital stay [ Time Frame: up time to discharge from hospital,an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
- incidence of postoperative morbidity [ Time Frame: up time to discharge from hospital,an expected average of 2 weeks ] [ Designated as safety issue: Yes ]After surgery, albumin, prophylactic broad-spectrum antibiotics, and enriched branched amino acid and fat emulsion (medium- and long-chain triglycerides), were given for 5-7 days until oral intake was possible.Ultrasonography-guided paracentesis or insertion of a second drainage tube was performed in patients with a subphrenic collection accompanied by fever (38.5◦C or higher) or a raised white blood cell count.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|No Intervention: Surgicel® absorbable Haemostat||
Device: Surgicel® absorbable Haemostat
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436721
|Shanghai, Shanghai, China, 200032|
|Principal Investigator:||Jia Fan, MD||Liver cancer institute, fudan university|