Status:
WITHDRAWN
Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Vascular Access Ports
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Adult patients requiring TIVAD insertion for long-term central venous access
- Patients able to give informed consent to participate in the study.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05304871
Start Date
January 1 2024
End Date
December 1 2027
Last Update
April 26 2024
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