Comparison of an Antibiotic Impregnated PICC Catheter Versus a Regular PICC Catheter in a Tertiary Care Setting

NCT ID: NCT01765738

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-09-30

Brief Summary

To determine whether antibiotic impregnated PICC catheters have a lower infection rate than a conventional PICC catheter in a tertiary care patient population. Secondary goals will be to determine if there is a difference between the two catheters with early and late infections, to determine the cost comparison including extra cost of treatment for a line related infection, to determine if there are any non-infectious related complication differences between the two catheters.

Detailed Description

All patients who are referred to VIR for a PICC line will be evaluated to see if they satisfy the inclusion/exclusion criteria. The study will be discussed with those who do and informed consent will be obtained from those wishing to participate. The patient will then be randomized to one of two types of PICC lines. All lines will be placed by identical technique. This will include sterile technique, placement via a vein of the upper arm using ultrasound guidance, and positioning of the catheter tip under fluoroscopic guidance. A database of all catheters placed will be kept. Records will be reviewed at 1 week, 30 days, and 60 days by the Interventional Radiology Fellow.Review will include length of time catheter was in place, whether treatment was completed, whether catheter was removed prematurely, the clinical reason for removal, results of other imaging tests, and results of cultures on any catheters removed for suspicion of infection. Any non-infectious complications related to the catheter will also be noted. The reviewer will be blinded to which catheter was used during the procedure.

Conditions

Peripherally Inserted Central Catheters

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Antibiotic coated PICC

Cook Medical Spectrum Turbo-Ject Minocycline/Rifampin Power-Injectable PICC (5fr double lumen or 6fr triple lumen)

Group Type: ACTIVE_COMPARATOR

PICC (Cook, Bard)

Intervention Type: DEVICE

Comparison of antibiotic coated PICC vs. non-coated PICC

Non-antibiotic coated PICC

Bard Access PowerPICC Power Injection PICCs (6fr double lumen or 6fr. triple lumen)

Group Type: ACTIVE_COMPARATOR

PICC (Cook, Bard)

Intervention Type: DEVICE

Comparison of antibiotic coated PICC vs. non-coated PICC

Interventions

PICC (Cook, Bard)

Comparison of antibiotic coated PICC vs. non-coated PICC

Intervention Type: DEVICE

Other Intervention Names

Minocycline/Rifampin Power-Injectable PICC; PowerPICC Power Injection PICCs

Eligibility Criteria

Inclusion Criteria

• Greater than or equal to 18 years of age
• Have been scheduled for a medically necessary PICC placement

Exclusion Criteria

• Less than 18 years of age

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J. Bayne Selby, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

PICC Line Comparison

Identifier Type: -

Identifier Source: org_study_id