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

Mayo Clinic

Status: Terminated

Conditions: Cardiovascular Disease

Treatments: Device: Cyanoacrylate tissue adhesive (Dermabond); Device: Polyglactin 910 suture (Vicryl)

Study type: Interventional

Funder types: Other

Identifiers

NCT00674128

07-001566

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Adhesive

Experimental group

Description:

Cyanoacrylate tissue adhesive.

Treatment:

Device: Cyanoacrylate tissue adhesive (Dermabond)

Suture

Active Comparator group

Description:

Polyglactin 910 suture.

Treatment:

Device: Polyglactin 910 suture (Vicryl)