Vascular Access PortsNCT05304871
Randomized Assessment of Antibiotic Prophylaxis Prior to Port Placement
A study testing Cefazolin and saline in people with Vascular Access Ports, run by Dartmouth-Hitchcock Medical Center.
Trial summary
A randomized, double blind, placebo-controlled clinical trial assessing the utility of antibiotic prophylaxis prior to Totally Implanted Venous Access Device (TIVAD) insertion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Ports
- What is being tested?
- Cefazolin and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients requiring TIVAD insertion for long-term central venous access
- Patients able to give informed consent to participate in the study.
Who cannot join
- 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.
About this study
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
A randomized, double blind, placebo-controlled clinical trial assessing the utility of antibiotic prophylaxis prior to Totally Implanted Venous Access Device (TIVAD) insertion.
Read the 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.
- Conditions
- Vascular Access Ports
- Being tested
- Cefazolin, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
infusion
salineOther
Also called placebo
infusion
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | patients receive saline infusion prior to port placement Receives: Other: saline |
| antibiotic | Experimental | patients receive antibiotic (Cefazolin 2 g) infusion prior to port placement Receives: Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days after procedure
Secondary outcomes (1)
Average cost of systemic prophylactic antibiotic administration compared to the cost of treating TIVAD insertion related infections
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
Measured: 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startJan 2024 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Study was not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access PortsStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric K. Hoffer, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304871
- Sponsor's protocol ID
- STUDY02000371
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2022
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05304871
- Acronym / sponsor ID
- STUDY02000371
- Conditions
- Vascular Access Ports
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: salinepatients receive saline infusion prior to port placement |
| antibiotic | Experimental | Drug: Cefazolinpatients receive antibiotic (Cefazolin 2 g) infusion prior to port placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients requiring TIVAD insertion for long-term central venous access
- Patients able to give informed consent to participate in the study.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefazolininfusion | Drug | antibiotic |
| salineAlso: placeboinfusion | Other | placebo |
Primary outcome
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
1 secondary outcome
Average cost of systemic prophylactic antibiotic administration compared to the cost of treating TIVAD insertion related infections
Time frame: 30 days after procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin and saline in people with Vascular Access Ports, run by Dartmouth-Hitchcock Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with surgical site infection (time frame: 30 days after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.