NCT00674128

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 29, 2010

Completed
Last Updated

December 29, 2010

Status Verified

December 1, 2010

Enrollment Period

1 year

First QC Date

May 5, 2008

Results QC Date

October 5, 2010

Last Update Submit

December 1, 2010

Conditions

Cardiovascular Disease

Keywords

pacemakercardioverter-defibrillatorICDcardiac resynchronization devicecyanoacrylatesutureDermabondVicryl

Outcome Measures

Primary Outcomes (1)

  • Reported Here Are the Number of Participants With Devices That Developed Infection

    Within 3 months after surgery.

Study Arms (2)

Adhesive

EXPERIMENTAL

Cyanoacrylate tissue adhesive.

Device: Cyanoacrylate tissue adhesive (Dermabond)

Suture

ACTIVE COMPARATOR

Polyglactin 910 suture.

Device: Polyglactin 910 suture (Vicryl)

Interventions

Cyanoacrylate tissue adhesive (Dermabond)DEVICE

Skin closure will be performed with cyanoacrylate tissue adhesive.

Also known as: Dermabond
Adhesive
Polyglactin 910 suture (Vicryl)DEVICE

Skin closure will be performed with polyglactin 910 suture.

Also known as: Vicryl
Suture

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Allergy to one of the closure materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

Title
Gregory Altemose MD
Organization
Mayo Clinic
altemose.gregory@mayo.edu
480-301-8000

Study Officials

  • Gregory Altemose, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 7, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 29, 2010

Results First Posted

December 29, 2010

Record last verified: 2010-12

Locations

US(1)