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

This study has been terminated.
(Slow accrual.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00674128
First received: May 5, 2008
Last updated: December 1, 2010
Last verified: December 2010
  Purpose

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
Cardiovascular Disease
Device: Cyanoacrylate tissue adhesive (Dermabond)
Device: Polyglactin 910 suture (Vicryl)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Comparison of Cyanoacrylate Tissue Adhesive (Dermabond) and Suture (Vicryl) for Closure of Cardiac Device Pockets

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Reported Here Are the Number of Participants With Devices That Developed Infection [ Time Frame: Within 3 months after surgery. ] [ Designated as safety issue: Yes ]

Enrollment: 103
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory Altemose, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00674128     History of Changes
Other Study ID Numbers: 07-001566
Study First Received: May 5, 2008
Results First Received: October 5, 2010
Last Updated: December 1, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014