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NCT00674128 Clinical Trial

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

Cardiovascular Disease Clinical Trial

Official title:
Prospective Comparison of Cyanoacrylate Tissue Adhesive (Dermabond) and Suture (Vicryl) for Closure of Cardiac Device Pockets

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00674128
Other study ID # 07-001566
Secondary ID
Status Terminated
Phase N/A
First received May 5, 2008
Last updated December 1, 2010
Start date May 2008
Est. completion date May 2009

Study information
Verified date December 2010
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Terminated
Enrollment 103
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Cyanoacrylate tissue adhesive (Dermabond)
Skin closure will be performed with cyanoacrylate tissue adhesive.
• Polyglactin 910 suture (Vicryl)
Skin closure will be performed with polyglactin 910 suture.

Locations
Country Name City State
United States Mayo Clinic Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reported Here Are the Number of Participants With Devices That Developed Infection Within 3 months after surgery. Yes
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