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Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

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ClinicalTrials.gov Identifier: NCT05304871
Recruitment Status : Withdrawn (Study was not funded)
First Posted : March 31, 2022
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
Eric K. Hoffer, Dartmouth-Hitchcock Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vascular Access Ports Drug: Cefazolin Other: saline Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Primary Purpose: Prevention
Official Title: A Randomized, Double Blind, Placebo-controlled Clinical Trial Assessing the Utility of Antibiotic Prophylaxis Prior to Totally Implanted Venous Access Device (TIVAD) Insertion
Estimated Study Start Date : January 2024
Estimated Primary Completion Date : March 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo
patients receive saline infusion prior to port placement
 Other: saline
infusion
Other Name: placebo
Experimental: antibiotic
patients receive antibiotic (Cefazolin 2 g) infusion prior to port placement
 Drug: Cefazolin
infusion


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Average cost of systemic prophylactic antibiotic administration compared to the cost of treating TIVAD insertion related infections [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Eric K. Hoffer, Director, Vascular and Interventional Radiology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT05304871    
Other Study ID Numbers: STUDY02000371
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents