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

Not Applicable

Terminated

• Conditions: Cardiovascular Disease
• Interventions: Device: Cyanoacrylate tissue adhesive (Dermabond); Device: Polyglactin 910 suture (Vicryl)

• Registration Number: NCT00674128
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2010-10-05
• Status Verified: 2010-12
• Results First Submitted QC: 2010-12-01
• Last Update Submitted: 2010-12-01
• Results First Posted: 2010-12-29
• Last Update Posted: 2010-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

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

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Exclusion Criteria

• Allergy to one of the closure materials.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adhesive	Cyanoacrylate tissue adhesive (Dermabond)	Cyanoacrylate tissue adhesive.
Suture	Polyglactin 910 suture (Vicryl)	Polyglactin 910 suture.

Primary Outcome Measures

Name	Time	Method
Reported Here Are the Number of Participants With Devices That Developed Infection	Within 3 months after surgery.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States