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Completed Phase 3 Interventional Results available

Perioperative Antibiotic Therapy to Prevent Cardiac Implantable Electronic Device Infections.

ClinicalTrials.gov ID: NCT02809131

Public ClinicalTrials.gov record NCT02809131. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Noninferiority Study of an Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients

Study identification

NCT ID
NCT02809131
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Vanderbilt University Medical Center
Other
Enrollment
1,010 participants

Conditions and interventions

Interventions

  • polymixin/bacitracin Drug
  • cephalexin, or levofloxacin, or clindamycin Drug
  • Saline Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2016
Primary completion
Mar 30, 2021
Completion
Sep 29, 2021
Last update posted
May 8, 2022

2016 – 2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Vanderbilt University Medical Center Nashville Tennessee 37232

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02809131, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 8, 2022 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02809131 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →