Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

Dartmouth-Hitchcock Medical Center

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

Vascular Access Ports

Interventions

CefazolinDRUG

infusion

salineOTHER

infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 30 days after procedure

Secondary Outcomes

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

Time frame: 30 days after procedure

Data from ClinicalTrials.gov

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