Vascular Access Ports
Conditions
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.
Interventions
DRUGCefazolin
infusion
OTHERsaline
infusion
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Placebo and antibiotic packaged similarly, code identified by Investigational Pharmacy. Patients and providers will not know which had been administered.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed