Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

A Randomized, Double Blind, Placebo-controlled Clinical Trial Assessing the Utility of Antibiotic Prophylaxis Prior to Totally Implanted Venous Access Device (TIVAD) Insertion

A randomized, double blind, placebo-controlled clinical trial assessing the utility of antibiotic prophylaxis prior to Totally Implanted Venous Access Device (TIVAD) insertion.

Study Overview

• Status: Withdrawn
• Conditions: Vascular Access Ports
• Intervention / Treatment: Other: saline; Drug: Cefazolin

Detailed Description

To assess the effectiveness of peri-procedural antibiotic prophylaxis in the reduction of TIVAD placement-related infection, study will compare placebo (normal saline (0.9% NaCl)) 50 cc IV 1:1 to the standard clinical antibiotic prophylaxis dose. The primary endpoint is cumulative incidence of local TIVAD surgical site infection (as determined by the CDC criteria for a deep and/or superficial SSI) or a central line associated blood stream infection at 30 days.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Hoffer, MD; Phone Number: 6036507417; Email: hoffer@hitchcock.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients requiring TIVAD insertion for long-term central venous access
• Patients able to give informed consent to participate in the study.

Exclusion Criteria:

• taking long-term antibiotics
• unable to give consent to participate in the study
• Patients that have a known infection at time of the procedure (as documented in e-DH).
• Patients with a planned surgical procedure within 30 days of initial TIVAD insertion.
• Patients that are currently on antibiotics or have received antibiotics within the last week.
• Patients with allergies to cefazolin.
• Patients with an absolute neutrophil count of less than 500/mm3
• Women who are pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; patients receive saline infusion prior to port placement	Other: saline; infusion; Other Names: placebo
Experimental: antibiotic; patients receive antibiotic (Cefazolin 2 g) infusion prior to port placement	Drug: Cefazolin; infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with surgical site infection	surgical site infection; Effectiveness will be evaluated by comparing infection rates between patients that receive systemic prophylactic antibiotic and those that receive a placebo	30 days after procedure
Number of participants with CRBSI	catheter-related bloodstream infection (CRBSI); Effectiveness will be evaluated by comparing infection rates between patients that receive systemic prophylactic antibiotic and those that receive a placebo	30 days after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average cost of systemic prophylactic antibiotic administration compared to the cost of treating TIVAD insertion related infections	expense associated with catheter or catheter-related complication care; compare the costs of systemic prophylactic antibiotic administration, prior to totally implanted central venous access device (TIVAD) insertion, to the cost of treating TIVAD insertion related infections	30 days after procedure

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: STUDY02000371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No