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

NCT ID: NCT00674128

Last Updated: 2010-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Cardiovascular Disease

Keywords

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pacemaker cardioverter-defibrillator ICD cardiac resynchronization device cyanoacrylate suture Dermabond Vicryl

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adhesive

Cyanoacrylate tissue adhesive.

Group Type EXPERIMENTAL

Cyanoacrylate tissue adhesive (Dermabond)

Intervention Type DEVICE

Skin closure will be performed with cyanoacrylate tissue adhesive.

Suture

Polyglactin 910 suture.

Group Type ACTIVE_COMPARATOR

Polyglactin 910 suture (Vicryl)

Intervention Type DEVICE

Skin closure will be performed with polyglactin 910 suture.

Interventions

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Cyanoacrylate tissue adhesive (Dermabond)

Skin closure will be performed with cyanoacrylate tissue adhesive.

Intervention Type DEVICE

Polyglactin 910 suture (Vicryl)

Skin closure will be performed with polyglactin 910 suture.

Intervention Type DEVICE

Other Intervention Names

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Dermabond Vicryl

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Gregory Altemose, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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07-001566

Identifier Type: -

Identifier Source: org_study_id