Study to Evaluate Safety & Effectiveness of Vascular Sealant System

NCT00439309 | Terminated Results DMC

• 1 other identifier: VAS-06-001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Sealing Success

  The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.

  Within 10 minutes following restoration of blood flow

Secondary Outcomes (4)

• Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)

  60 seconds post restoration of blood flow

• Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)

  Within 10 minutes post restoration of blood flow

• Time to Hemostasis

  Within 10 minutes post restoration of blood flow

• Time to Wound Closure

  From initial clamp removal at the last anastomotic site until skin closure

Study Arms (2)

VascuSeal

EXPERIMENTAL

Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.

Device: VascuSeal

GELFOAM/THROMBIN

ACTIVE COMPARATOR

GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.

Device: Gelfoam/Thrombin

Interventions

Gelfoam/Thrombin DEVICE

Gelfoam/Thrombin

Also known as: absorbable gelatin compressed sponge

GELFOAM/THROMBIN

VascuSeal DEVICE

VascuSeal

Also known as: Vascular Sealant System

VascuSeal

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (1)

Confluent Surgical, Inc.

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

• Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.

  PMID: 38695613 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Gelatin Sponge, Absorbable

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Director, Medical Affairs
• Organization: Integra LifeSciences

609-275-0500

Study Officials

• Vladimir I Scerbin

  Confluent Surgical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 23, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 7, 2017
• Results First Posted: April 1, 2014

Record last verified: 2017-08

Locations

US (1)