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Use of an Oxidized Regenerated Cellulose After Hepatic Surgery

Primary Purpose

Liver Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Surgicel® absorbable Haemostat

About this trial

This is an interventional treatment trial for Liver Neoplasms focused on measuring Effectiveness, Device success, Hepatectomy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Surgicel® absorbable Haemostat

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

time to removal of wound drain

length of postoperative hospital stay

incidence of postoperative morbidity

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.

Full Information

NCT ID

NCT01436721

First Posted

September 13, 2011

Last Updated

September 19, 2011

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01436721

Brief Title

Use of an Oxidized Regenerated Cellulose After Hepatic Surgery

Official Title

The Randomized Clinical Trial of Surgicel® Absorbable Haemostat Covering the Raw Cut Surface During the Hepatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

August 2011 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Neoplasms

Keywords

Effectiveness, Device success, Hepatectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgicel® absorbable Haemostat

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

Surgicel® absorbable Haemostat

Intervention Description

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.

Primary Outcome Measure Information:

Title

the size of any subphrenic collection or pleural effusion

Description

Time Frame

up time to the drainage tube removed, an expected average of 1 week

Secondary Outcome Measure Information:

Title

time to removal of wound drain

Time Frame

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

Title

length of postoperative hospital stay

Time Frame

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

Title

incidence of postoperative morbidity

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jia Fan, MD

Organizational Affiliation

Liver cancer institute, fudan university

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

zheng wang, MD

Phone

64041990

Ext

64041990

wang.zheng@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Jia Fan, MD

12. IPD Sharing Statement

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Use of an Oxidized Regenerated Cellulose After Hepatic Surgery

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