Clinical trial NCT00439309: Study to Evaluate Safety & Effectiveness of Vascular Sealant System
Official title: Randomized Study to Evaluate Safety & Effectiveness of Vascular Sealant to Control Suture Line Bleeding
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2007-02-23
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.

Detailed description: Vascular surgery encompasses a wide range of surgical procedures. In these procedures reduction of blood loss and creation of suture line is of utmost importance to the surgeon. Bleeding at the suture line may require transfusion, as well as prolonged operative and anesthesia time. Suture hole bleeding is common following using synthetic and biological grafts for vascular repair. Several topical hemostatic ans sealing agents have been developed to control suture line bleeding. This new vascular sealant possess high bonding properties, minimal tissue reaction, is biodegradable and absorbed by the body quickly. The primary focus of this study is to compare the safety and effectiveness of the vascular sealant with standard of care methods used today, specifically gelfoam/thrombin and sponge like material.

Eligibility criteria: Inclusion Criteria:

Subject was \> 18 years of age. Scheduled for elective vascular surgery that entails placement of a PTFE vascular graft including extra-anatomic, infrainguinal bypass, and primary and secondary arteriovenous access procedures. Subject was willing and able to comply with all aspects of the treatment and evaluation schedule. Informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site

Exclusion Criteria:

Subject had a known local or systemic infection. Subjects with known coagulopathies including hemophilia, factor deficiencies, platelet count \< 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR \> 1.5. Subject was participating in a clinical trial that requires treatment with another investigational device or drug. Subject was lactating or pregnant, or does not agree to use contraception for the duration of the study. Subject had a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin. The investigator determined that the subject should not be included in the study for reason(s) not already specified

Primary outcomes:
measure: Sealing Success
timeFrame: Within 10 minutes following restoration of blood flow
Secondary outcomes:
measure: Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)
timeFrame: 60 seconds post restoration of blood flow
measure: Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)
timeFrame: Within 10 minutes post restoration of blood flow
measure: Time to Hemostasis
timeFrame: Within 10 minutes post restoration of blood flow
measure: Time to Wound Closure
timeFrame: From initial clamp removal at the last anastomotic site until skin closure
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Confluent Surgical, Inc.
state: Massachusetts
Study officials:
affiliation: Confluent Surgical
name: Vladimir I Scerbin
role: STUDY_DIRECTOR
References: