Use of an Oxidized Regenerated Cellulose After Hepatic Surgery

NCT01436721 | Unknown Phase 2 DMC

• 1 other identifier: LCI-125-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Neoplasms

Keywords

Effectiveness; Device success; Hepatectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• time to removal of wound drain

  up time to removal of wound drain, an expected average of 1 week

• length of postoperative hospital stay

  up time to discharge from hospital,an expected average of 2 weeks

• incidence of postoperative morbidity

  up time to discharge from hospital,an expected average of 2 weeks

Study Arms (1)

Surgicel® absorbable Haemostat

NO INTERVENTION

Device: Surgicel® absorbable Haemostat

Interventions

Surgicel® absorbable Haemostat DEVICE

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.

Surgicel® absorbable Haemostat

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Jia Fan, MD

  Liver cancer institute, fudan university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of zhongshan hospital

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 20, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

CN (1)