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, FACC265 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

265

Conditions

Infection

Interventions

ICD/pacemaker pocket revisionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Hospital

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever

Time frame: 1 year

Secondary Outcomes

If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained

Time frame: 1 year

Data from ClinicalTrials.gov

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