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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00674128 |
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 | Intervention |
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Cardiovascular Disease |
Device: Cyanoacrylate tissue adhesive (Dermabond) Device: Polyglactin 910 suture (Vicryl) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective Comparison of Cyanoacrylate Tissue Adhesive (Dermabond) and Suture (Vicryl) for Closure of Cardiac Device Pockets |
Estimated Enrollment: | 600 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Adhesive: Experimental
Cyanoacrylate tissue adhesive.
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Device: Cyanoacrylate tissue adhesive (Dermabond)
Skin closure will be performed with cyanoacrylate tissue adhesive.
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Suture: Active Comparator
Polyglactin 910 suture.
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Device: Polyglactin 910 suture (Vicryl)
Skin closure will be performed with polyglactin 910 suture.
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jacklyn Gentry, RN | 480-301-8000 |
United States, Arizona | |
Mayo Clinic | Recruiting |
Phoenix, Arizona, United States, 85054 | |
Principal Investigator: Gregory Altemose, M.D. |
Principal Investigator: | Gregory Altemose, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Gregory Altemose, M.D. ) |
Study ID Numbers: | 07-001566 |
Study First Received: | May 5, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00674128 |
Health Authority: | United States: Institutional Review Board |
pacemaker cardioverter-defibrillator ICD cardiac resynchronization device |
cyanoacrylate suture Dermabond Vicryl |
Cardiovascular Diseases |