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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

Sponsor
Dhanunjaya Lakkireddy, MD, FACC (Other)
Overall Status
Completed
CT.gov ID
NCT00599261
Collaborator
(none)
265
Enrollment
1
Location
2
Arms
59
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: ICD/pacemaker pocket revision
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
265 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age 18 years or greater

  2. Willingness to provide written informed consent

  3. Subjects presenting for any of the following:

  4. pacemaker/ICD generator change

  5. pacemaker/ICD lead replacement

  6. pacemaker/ICD lead revision

  7. 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

Locations

Site City State Country Postal Code
1 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 Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dhanunjaya Lakkireddy, MD, FACC, Associate Professor of Medicine, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00599261
Other Study ID Numbers:
  • 10995
First Posted:
Jan 23, 2008
Last Update Posted:
Jan 10, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Dhanunjaya Lakkireddy, MD, FACC, Associate Professor of Medicine, University of Kansas Medical Center
Cardiac Pacemaker, Artificial
Additional relevant MeSH terms:
Infections
Communicable Diseases

Study Results

No Results Posted as of Jan 10, 2013