Peripheral Vascular DiseaseNCT00439309
Study to Evaluate Safety & Effectiveness of Vascular Sealant System
A study testing Gelfoam/Thrombin and VascuSeal in people with Peripheral Vascular Disease, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Gelfoam/Thrombin and VascuSeal
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to May 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Confluent Surgical, Inc.
Waltham, Massachusetts, 02451
About this study
Official title: Randomized Study to Evaluate Safety & Effectiveness of Vascular Sealant to Control Suture Line Bleeding
To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
Read the 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.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Gelfoam/Thrombin, VascuSeal
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelfoam/ThrombinDevice
Also called absorbable gelatin compressed sponge
Gelfoam/Thrombin
VascuSealDevice
Also called Vascular Sealant System
VascuSeal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Gelfoam/Thrombin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 10 minutes following restoration of blood flow
Secondary outcomes (4)
Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)
A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow
Measured: 60 seconds post restoration of blood flow
Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)
A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow.
Measured: Within 10 minutes post restoration of blood flow
Time to Hemostasis
Time to hemostasis determined from time circulation restored after treatment application until bleeding stopped (assessed at intervals of immediate, 1, 3, 5, 7.5 and 10 min). For subject with two sites, time to hemostasis of both sites used for analysis. Subjects for whom bleeding had not stopped within 10 min considered censored observations.
Measured: Within 10 minutes post restoration of blood flow
Time to Wound Closure
Time to wound closure was defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. This endpoint was analyzed using the log-rank test to compare the two treatment groups. The Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group.
Measured: From initial clamp removal at the last anastomotic site until skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir I Scerbin, Study director, Confluent Surgical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439309
- Sponsor's protocol ID
- VAS-06-001
- Status last verified
- Aug 2017
- First submitted
- 21 Feb 2007
- Last updated
- 7 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 38695613
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study to Evaluate Safety & Effectiveness of Vascular Sealant to Control Suture Line Bleeding
- ClinicalTrials.gov ID
- NCT00439309
- Acronym / sponsor ID
- VAS-06-001
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Posted 1 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VascuSeal | Experimental | Device: VascuSealConsists 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. |
| GELFOAM/THROMBIN | Active comparator | Device: Gelfoam/ThrombinGELFOAM/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gelfoam/ThrombinAlso: absorbable gelatin compressed spongeGelfoam/Thrombin | Device | GELFOAM/THROMBIN |
| VascuSealAlso: Vascular Sealant SystemVascuSeal | Device | VascuSeal |
Primary outcome
Sealing Success
Time frame: Within 10 minutes following restoration of blood flow
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.
4 secondary outcomes
Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)
Time frame: 60 seconds post restoration of blood flow
Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)
Time frame: Within 10 minutes post restoration of blood flow
Time to Hemostasis
Time frame: Within 10 minutes post restoration of blood flow
Time to Wound Closure
Time frame: From initial clamp removal at the last anastomotic site until skin closure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38695613Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir I Scerbin study director
Confluent Surgical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelfoam/Thrombin and VascuSeal in people with Peripheral Vascular Disease, run by Integra LifeSciences Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sealing Success (time frame: Within 10 minutes following restoration of blood flow). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00439309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.