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Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets

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ClinicalTrials.gov Identifier: NCT00674128
Recruitment Status : Terminated (Slow accrual.)
First Posted : May 7, 2008
Results First Posted : December 29, 2010
Last Update Posted : December 29, 2010
Sponsor:
Information provided by:
Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Device: Cyanoacrylate tissue adhesive (Dermabond) Device: Polyglactin 910 suture (Vicryl) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Comparison of Cyanoacrylate Tissue Adhesive (Dermabond) and Suture (Vicryl) for Closure of Cardiac Device Pockets
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: Adhesive
Cyanoacrylate tissue adhesive.
Device: Cyanoacrylate tissue adhesive (Dermabond)
Skin closure will be performed with cyanoacrylate tissue adhesive.
Other Name: Dermabond
Active Comparator: Suture
Polyglactin 910 suture.
Device: Polyglactin 910 suture (Vicryl)
Skin closure will be performed with polyglactin 910 suture.
Other Name: Vicryl



Primary Outcome Measures :
  1. Reported Here Are the Number of Participants With Devices That Developed Infection [ Time Frame: Within 3 months after surgery. ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for implantation of a pacemaker or ICD in the deltopectoral region at Mayo Clinic Hospital in Phoenix.

Exclusion Criteria:

  • Allergy to one of the closure materials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674128


Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Gregory Altemose, M.D. Mayo Clinic

Additional Information:
Responsible Party: Gregory Altemose, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00674128     History of Changes
Other Study ID Numbers: 07-001566
First Posted: May 7, 2008    Key Record Dates
Results First Posted: December 29, 2010
Last Update Posted: December 29, 2010
Last Verified: December 2010

Keywords provided by Mayo Clinic:
pacemaker
cardioverter-defibrillator
ICD
cardiac resynchronization device
cyanoacrylate
suture
Dermabond
Vicryl

Additional relevant MeSH terms:
Cardiovascular Diseases