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

Dhanunjaya Lakkireddy, MD, FACC

Status and phase: Completed; Phase 4

Conditions: Infection

Treatments: Procedure: ICD/pacemaker pocket revision

Study type: Interventional

Funder types: Other

Identifiers

NCT00599261

10995 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 265 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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265 participants in 2 patient groups

1

Experimental group

Description:

Removal of the fibrotic pocket surrounding the generator and leads

Treatment:

Procedure: ICD/pacemaker pocket revision

2

Experimental group

Description:

Tissue is not removed

Treatment:

Procedure: ICD/pacemaker pocket revision