Use of an Oxidized Regenerated Cellulose After Hepatic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jia Fan, Fudan University
ClinicalTrials.gov Identifier:
NCT01436721
First received: September 13, 2011
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Liver Neoplasms
Device: Surgicel® absorbable Haemostat
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
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)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436721

Locations
China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: zheng wang, MD    64041990 ext 64041990    wang.zheng@zs-hospital.sh.cn   
Principal Investigator: Jia Fan, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jia Fan, MD Liver cancer institute, fudan university
  More Information

No publications provided

Responsible Party: Jia Fan, Vice President of zhongshan hospital, Fudan University
ClinicalTrials.gov Identifier: NCT01436721     History of Changes
Other Study ID Numbers: LCI-125-001
Study First Received: September 13, 2011
Last Updated: September 19, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Effectiveness
Device success
Hepatectomy

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 22, 2014