A Randomized, Double Blind, Placebo-controlled Clinical Trial Assessing the Utility of Antibiotic Prophylaxis Prior to Totally Implanted Venous Access Device (TIVAD) Insertion
Overview
- Phase
- Not Applicable
- Intervention
- saline
- Conditions
- Vascular Access Ports
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary Endpoint
- Number of participants with CRBSI
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eric K. Hoffer
Director, Vascular and Interventional Radiology
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
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.
Arms & Interventions
placebo
patients receive saline infusion prior to port placement
Intervention: saline
antibiotic
patients receive antibiotic (Cefazolin 2 g) infusion prior to port placement
Intervention: Cefazolin
Outcomes
Primary Outcomes
Number of participants with CRBSI
Time Frame: 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
Time Frame: 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 Outcomes
- Average cost of systemic prophylactic antibiotic administration compared to the cost of treating TIVAD insertion related infections(30 days after procedure)