Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

NCT05304871 | Withdrawn DMC

• 1 other identifier: STUDY02000371
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vascular Access Ports

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Average cost of systemic prophylactic antibiotic administration compared to the cost of treating TIVAD insertion related infections

  30 days after procedure

Study Arms (2)

placebo

PLACEBO COMPARATOR

patients receive saline infusion prior to port placement

Other: saline

antibiotic

EXPERIMENTAL

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

Drug: Cefazolin

Interventions

Cefazolin DRUG

infusion

antibiotic

saline OTHER

infusion

Also known as: placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients requiring TIVAD insertion for long-term central venous access
• Patients able to give informed consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

MeSH Terms

Interventions

Cefazolin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo and antibiotic packaged similarly, code identified by Investigational Pharmacy. Patients and providers will not know which had been administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Vascular and Interventional Radiology

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: January 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share