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Completed

NCT Number: NCT00599261

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

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.

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Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

About this study

This is a randomized, prospective, single-blind study that evaluates the effect of removal of scar tissue during pacemaker/ICD pocket revision on infection and complications. Subjects will be randomly assigned to either removal of the scar tissue surrounding the implanted device during device replacement or to device replacement without removal of this tissue. Subjects will be followed for one year post-procedure for the occurrence of infection, bleeding/hematoma, or other complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ICD/pacemaker pocket revision

Procedure

Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads

Primary outcomes

  1. Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever

    Time frame: 1 year

Secondary outcomes

  1. If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Dhanunjaya Lakkireddy, MD, FACC

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jan 23, 2008
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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