Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05304871

Collaborator

(none)

2,550

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

2550 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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo patients receive saline infusion prior to port placement	Other: saline infusion Other Names: placebo
Experimental: antibiotic patients receive antibiotic (Cefazolin 2 g) infusion prior to port placement	Drug: Cefazolin infusion

Arm

Intervention/Treatment

Placebo Comparator: placebo

patients receive saline infusion prior to port placement

Other: saline

infusion

Other Names:

placebo

Experimental: antibiotic

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

Drug: Cefazolin

infusion

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Mar 31, 2022

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cefazolin

Study Results

No Results Posted as of Aug 10, 2022