Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement

• ClinicalTrials.gov Identifier: NCT05304871
• Recruitment Status: Withdrawn
• First Posted: March 31, 2022
• Last Update Posted: April 26, 2024
• Sponsor: Dartmouth-Hitchcock Medical Center
• Information provided by (Responsible Party): Eric K. Hoffer, Dartmouth-Hitchcock Medical Center

Tracking Information

• First Submitted Date: March 22, 2022
• First Posted Date: March 31, 2022
• Last Update Posted Date: April 26, 2024
• Estimated Study Start Date: January 2024
• Estimated Primary Completion Date: March 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 22, 2022)

• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 22, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement
• 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
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Vascular Access Ports

Intervention

• Drug: Cefazolin
  infusion
• Other: saline
  infusion
  Other Name: placebo

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 24, 2024): 0
• Original Estimated Enrollment (submitted: March 22, 2022): 2550
• Estimated Study Completion Date: December 2027
• Estimated Primary Completion Date: March 2027 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05304871
• Other Study ID Numbers: STUDY02000371
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Eric K. Hoffer, Dartmouth-Hitchcock Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Dartmouth-Hitchcock Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Dartmouth-Hitchcock Medical Center
• Verification Date: April 2024