Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vascular Access Ports

Intervention / Treatment
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* Drug: Cefazolin
* Other: saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>patients receive saline infusion prior to port placement | Other: saline<br>* infusion<br>* Other names: placebo;|
| Experimental: antibiotic<br>patients receive antibiotic (Cefazolin 2 g) infusion prior to port placement | Drug: Cefazolin<br>* infusion<br>|

What is the study measuring?
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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 |