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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00599261

Enrollment

265

Registered

2008-01-23

Start date

2008-01-31

Completion date

2012-12-31

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Cardiac Pacemaker, Artificial

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.

Interventions

PROCEDUREICD/pacemaker pocket revision

Pocket revision consists of complete removal of the fibrous capsule surrounding the device and leads

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026