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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00599261
First received: January 11, 2008
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Infection
Procedure: ICD/pacemaker pocket revision
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 265
Study Start Date: January 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Removal of the fibrotic pocket surrounding the generator and leads
Procedure: ICD/pacemaker pocket revision
Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads
Experimental: 2
Tissue is not removed
Procedure: ICD/pacemaker pocket revision
Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or greater
  2. Willingness to provide written informed consent
  3. Subjects presenting for any of the following:

    1. pacemaker/ICD generator change
    2. pacemaker/ICD lead replacement
    3. pacemaker/ICD lead revision
    4. pacemaker/ICD upgrades

Exclusion Criteria:

  1. Age less than 18 years
  2. Unwillingness to provide written informed consent
  3. Subjects unable to give consent
  4. Pregnant or nursing women
  5. Patients who have undergone pocket revision or manipulation less than 365 days prior
  6. Patients who have undergone pacemaker or ICD implantation less than 365 days prior
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599261

Locations
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas
  More Information

No publications provided

Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Associate Professor of Medicine, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00599261     History of Changes
Other Study ID Numbers: 10995
Study First Received: January 11, 2008
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Cardiac Pacemaker, Artificial

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on November 19, 2014