Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets - Full Text View

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

This study is currently recruiting participants.
Verified by Mayo Clinic, May 2008

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00674128

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)

U.S. FDA Resources

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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

The primary outcome measure is whether the device pocket developed infection. [ Time Frame: Within 3 months after surgery. ] [ Designated as safety issue: No ]

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674128

Contacts


Contact: Jacklyn Gentry, RN	480-301-8000

Locations


United States, Arizona
	Mayo Clinic	Recruiting
	Phoenix, Arizona, United States, 85054
	Principal Investigator: Gregory Altemose, M.D.

Sponsors and Collaborators

Mayo Clinic

Investigators


Principal Investigator:	Gregory Altemose, M.D.	Mayo Clinic

More Information

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Mayo Clinic ( Gregory Altemose, M.D. )
Study ID Numbers:	07-001566
First Received:	May 5, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00674128
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 October 23, 2008