Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2027-12-31

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.

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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.

Conditions

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Vascular Access Ports

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Placebo and antibiotic packaged similarly, code identified by Investigational Pharmacy. Patients and providers will not know which had been administered.

Study Groups

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placebo

patients receive saline infusion prior to port placement

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

infusion

antibiotic

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

Group Type EXPERIMENTAL

Cefazolin

Intervention Type DRUG

infusion

Interventions

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Cefazolin

infusion

Intervention Type DRUG

saline

infusion

Intervention Type OTHER

Other Intervention Names

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placebo

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No