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 Overview
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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.

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.

Official Title
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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

Conditions
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Infection

Intervention / Treatment
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* Procedure: ICD/pacemaker pocket revision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or greater Willingness to provide written informed consent Subjects presenting for any of the following: pacemaker/ICD generator change pacemaker/ICD lead replacement pacemaker/ICD lead revision pacemaker/ICD upgrades Exclusion Criteria: Age less than 18 years Unwillingness to provide written informed consent Subjects unable to give consent Pregnant or nursing women Patients who have undergone pocket revision or manipulation less than 365 days prior Patients who have undergone pacemaker or ICD implantation less than 365 days prior

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Removal of the fibrotic pocket surrounding the generator and leads | Procedure: ICD/pacemaker pocket revision<br>* Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads<br>|
| Experimental: 2<br>Tissue is not removed | Procedure: ICD/pacemaker pocket revision<br>* Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Pacemaker, Artificial