Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

Dartmouth Health

Status: Withdrawn

Conditions: Vascular Access Ports

Treatments: Drug: Cefazolin; Other: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05304871

STUDY02000371

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

patients receive saline infusion prior to port placement

Treatment:

Other: saline

antibiotic

Experimental group

Description:

patients receive antibiotic (Cefazolin 2 g) infusion prior to port placement

Treatment:

Drug: Cefazolin