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

January 11, 2008
January 8, 2013
January 2008
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00599261 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Infection
Procedure: ICD/pacemaker pocket revision
Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads
  • Experimental: 1
    Removal of the fibrotic pocket surrounding the generator and leads
    Intervention: Procedure: ICD/pacemaker pocket revision
  • Experimental: 2
    Tissue is not removed
    Intervention: Procedure: ICD/pacemaker pocket revision
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
265
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00599261
10995
Yes
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center Research Institute
Dhanunjaya Lakkireddy, MD, FACC
Not Provided
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas
University of Kansas
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP