Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

Not Applicable

Withdrawn

• Conditions: Vascular Access Ports
• Interventions: Drug: Cefazolin; Other: saline

• Registration Number: NCT05304871
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Study Start: 2024-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26
• Primary Completion: 2027-03
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antibiotic	Cefazolin	patients receive antibiotic (Cefazolin 2 g) infusion prior to port placement
placebo	saline	patients receive saline infusion prior to port placement

Primary Outcome Measures

Name	Time	Method
Number of participants with CRBSI	30 days after procedure	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
Number of participants with surgical site infection	30 days after procedure	surgical site infection; Effectiveness will be evaluated by comparing infection rates between patients that receive systemic prophylactic antibiotic and those that receive a placebo

Secondary Outcome Measures

Name	Time	Method
Average cost of systemic prophylactic antibiotic administration compared to the cost of treating TIVAD insertion related infections	30 days after procedure	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