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

January 8, 2013 updated by: Dhanunjaya Lakkireddy, MD, FACC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

265

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dhanunjaya Lakkireddy, MD, FACC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (ESTIMATE)

January 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10995 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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