MAKE IT CLEAN, Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study

Completed · Phase 4

Conditions studied: Infection

In brief

To determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.

Key facts

Study ID

NCT00599261

Run by

Dhanunjaya Lakkireddy, MD, FACC

People needed

265

Starts

2008-01-01

Expected to finish

2012-12-01

Last updated by the study team

2013-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or greater
• Willingness to provide written informed consent
• Subjects presenting for any of the following:
• pacemaker/ICD generator change
• pacemaker/ICD lead replacement
• pacemaker/ICD lead revision
• pacemaker/ICD upgrades

You may not qualify if…

• Age less than 18 years
• Unwillingness to provide written informed consent
• Subjects unable to give consent
• Pregnant or nursing women
• Patients who have undergone pocket revision or manipulation less than 365 days prior
• Patients who have undergone pacemaker or ICD implantation less than 365 days prior

Where it is running

• University of Kansas Hospital — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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