Cardiovascular DiseaseNCT00674128
Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets
A study testing Cyanoacrylate tissue adhesive (Dermabond) and Polyglactin 910 suture (Vicryl) in people with Cardiovascular Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Cyanoacrylate tissue adhesive (Dermabond) and Polyglactin 910 suture (Vicryl)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2009
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for implantation of a pacemaker or ICD in the deltopectoral region at Mayo Clinic Hospital in Phoenix.
Who cannot join
- Allergy to one of the closure materials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparison of Cyanoacrylate Tissue Adhesive (Dermabond) and Suture (Vicryl) for Closure of Cardiac Device Pockets
The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.
- Conditions
- Cardiovascular Disease
- Being tested
- Cyanoacrylate tissue adhesive (Dermabond), Polyglactin 910 suture (Vicryl)
- Keywords
- pacemaker, cardioverter-defibrillator, ICD, cardiac resynchronization device, cyanoacrylate, suture, Dermabond, Vicryl
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate tissue adhesive (Dermabond)Device
Also called Dermabond
Skin closure will be performed with cyanoacrylate tissue adhesive.
Polyglactin 910 suture (Vicryl)Device
Also called Vicryl
Skin closure will be performed with polyglactin 910 suture.
| Study group | Role | What they receive |
|---|---|---|
| Adhesive | Experimental | Cyanoacrylate tissue adhesive. Receives: Device: Cyanoacrylate tissue adhesive (Dermabond) |
| Suture | Active comparator | Polyglactin 910 suture. Receives: Device: Polyglactin 910 suture (Vicryl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported Here Are the Number of Participants With Devices That Developed Infection
Measured: Within 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Slow accrual.
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.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Gregory Altemose, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674128
- Sponsor's protocol ID
- 07-001566
- Status last verified
- Dec 2010
- First submitted
- 5 May 2008
- Last updated
- 29 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Cyanoacrylate Tissue Adhesive (Dermabond) and Suture (Vicryl) for Closure of Cardiac Device Pockets
- ClinicalTrials.gov ID
- NCT00674128
- Acronym / sponsor ID
- 07-001566
- Conditions
- Cardiovascular Disease
- Keywords
- pacemaker, cardioverter-defibrillator, ICD, cardiac resynchronization device, cyanoacrylate, suture, Dermabond, Vicryl
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 29 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adhesive | Experimental | Device: Cyanoacrylate tissue adhesive (Dermabond)Cyanoacrylate tissue adhesive. |
| Suture | Active comparator | Device: Polyglactin 910 suture (Vicryl)Polyglactin 910 suture. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for implantation of a pacemaker or ICD in the deltopectoral region at Mayo Clinic Hospital in Phoenix.
Key exclusion criteria (1 listed)
- Allergy to one of the closure materials.
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 |
|---|---|---|
| Cyanoacrylate tissue adhesive (Dermabond)Also: DermabondSkin closure will be performed with cyanoacrylate tissue adhesive. | Device | Adhesive |
| Polyglactin 910 suture (Vicryl)Also: VicrylSkin closure will be performed with polyglactin 910 suture. | Device | Suture |
Primary outcome
Reported Here Are the Number of Participants With Devices That Developed Infection
Time frame: Within 3 months after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gregory Altemose, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyanoacrylate tissue adhesive (Dermabond) and Polyglactin 910 suture (Vicryl) in people with Cardiovascular Disease, run by Mayo Clinic 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 29 Dec 2010. 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 29 Dec 2010). 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?
Reported Here Are the Number of Participants With Devices That Developed Infection (time frame: Within 3 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2010.