Clinical trial NCT00599261: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection
Keywords: Cardiac Pacemaker, Artificial
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever
timeFrame: 1 year
Secondary outcomes:
measure: If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained
timeFrame: 1 year
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.