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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

Primary Purpose

Infection

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ICD/pacemaker pocket revision
Sponsored by
Dhanunjaya Lakkireddy, MD, FACC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection focused on measuring Cardiac Pacemaker, Artificial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Kansas Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Removal of the fibrotic pocket surrounding the generator and leads

Tissue is not removed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2008
Last Updated
January 8, 2013
Sponsor
Dhanunjaya Lakkireddy, MD, FACC
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1. Study Identification

Unique Protocol Identification Number
NCT00599261
Brief Title
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
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dhanunjaya Lakkireddy, MD, FACC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Cardiac Pacemaker, Artificial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
265 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Removal of the fibrotic pocket surrounding the generator and leads
Arm Title
2
Arm Type
Experimental
Arm Description
Tissue is not removed
Intervention Type
Procedure
Intervention Name(s)
ICD/pacemaker pocket revision
Intervention Description
Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads
Primary Outcome Measure Information:
Title
Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever
Time Frame
1 year
Secondary Outcome Measure Information:
Title
If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25625720
Citation
Lakkireddy D, Pillarisetti J, Atkins D, Biria M, Reddy M, Murray C, Bommana S, Shanberg D, Adabala N, Pimentel R, Dendi R, Emert M, Vacek J, Dawn B, Berenbom L. 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 (MAKE IT CLEAN): A prospective randomized study. Heart Rhythm. 2015 May;12(5):950-6. doi: 10.1016/j.hrthm.2015.01.035. Epub 2015 Jan 24.
Results Reference
derived

Learn more about this trial

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

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