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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Removal of the fibrotic pocket surrounding the generator and leads

Group Type EXPERIMENTAL

ICD/pacemaker pocket revision

Intervention Type PROCEDURE

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

2

Tissue is not removed

Group Type EXPERIMENTAL

ICD/pacemaker pocket revision

Intervention Type PROCEDURE

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

Interventions

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ICD/pacemaker pocket revision

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No