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

Phase 4

Completed

• Conditions: Infection
• Interventions: Procedure: ICD/pacemaker pocket revision

• Registration Number: NCT00599261
• Lead Sponsor: Dhanunjaya Lakkireddy, MD, FACC

Brief 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.

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-08
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ICD/pacemaker pocket revision	Removal of the fibrotic pocket surrounding the generator and leads
2	ICD/pacemaker pocket revision	Tissue is not removed

Primary Outcome Measures

Name	Time	Method
Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever	1 year

Secondary Outcome Measures

Name	Time	Method
If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained	1 year

Trial Locations

Locations (1)

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States