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CompletedNCT00599261Updated Jan 10, 2013

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

A Phase 4 interventional study of ICD/pacemaker pocket revision in Infection, sponsored by Dhanunjaya Lakkireddy, MD, FACC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.

Sponsored by Dhanunjaya Lakkireddy, MD, FACC · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
265
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infection

Keywords

  • Cardiac Pacemaker, Artificial
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 265 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Dhanunjaya Lakkireddy, MD, FACC is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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:

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
265 participants (estimated)

Study arms

  • Experimental
    1

    Removal of the fibrotic pocket surrounding the generator and leads

    Procedure: ICD/pacemaker pocket revision

  • Experimental
    2

    Tissue is not removed

    Procedure: ICD/pacemaker pocket revision

Interventions

  • ProcedureICD/pacemaker pocket revision

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

06

What researchers measure

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

07

Study locations

1 site
  • University of Kansas Hospital
    Kansas City, Kansas 66160, United States
08

References and documents

Publications

  • Lakkireddy D, Pillarisetti J, Atkins D, Biria M, Reddy M, Murray C, Bommana S, Shanberg D, Adabala N, Pimentel R, Dendi R, Emert M, Vacek J, Dawn B, Berenbom L. 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 (MAKE IT CLEAN): A prospective randomized study. Heart Rhythm. 2015 May;12(5):950-6. doi: 10.1016/j.hrthm.2015.01.035. Epub 2015 Jan 24. PubMed 25625720 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00599261
Lead sponsor
Dhanunjaya Lakkireddy, MD, FACC
Responsible party
Dhanunjaya Lakkireddy, MD, FACC (Associate Professor of Medicine, University of Kansas Medical Center) — Sponsor-investigator
First posted
Jan 23, 2008
Start date
Jan 2008
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jan 10, 2013

Study contacts

Dhanunjaya Lakkireddy, MD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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