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

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599261
• Other study ID #: 10995
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2008
• Last updated: January 8, 2013
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection

Intervention

Procedure:
• ICD/pacemaker pocket revision
Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads

Locations

Country	Name	City	State
United States	University of Kansas Hospital	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Dhanunjaya Lakkireddy, MD, FACC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever		1 year	Yes
Secondary	If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained		1 year	Yes