Impact of Pocket Revision on Infection Rates - Full Text View

Sponsored by:	University of Kansas
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00599261

Purpose

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.

Condition	Intervention	Phase
Infection	Procedure: ICD/pacemaker pocket revision	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy 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

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	265
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Removal of the fibrotic pocket surrounding the generator and leads	Procedure: ICD/pacemaker pocket revision Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads
2: Experimental Tissue is not removed	Procedure: ICD/pacemaker pocket revision Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 years or greater
Willingness to provide written informed consent
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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599261

Locations

United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas

Investigators

Principal Investigator:

Dhanunjaya Lakkireddy, MD

University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Dhanunjaya Lakkireddy, MD )
Study ID Numbers:	10995
Study First Received:	January 11, 2008
Last Updated:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00599261
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

Cardiac Pacemaker, Artificial

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 14, 2009