InfectionNCT02027532
Prevention of Infection in Closed Fractures: Cefazolin Versus Vancomycin
A study testing Cefazolin and Vancomycin in people with Infection and Closed Fractures, run by University of Tennessee at 1 site in United States.
Trial summary
The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Infection, Closed Fractures
- What is being tested?
- Cefazolin and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 years old and 85 years old
- Closed fracture
- Fracture treatment plan is for one operation on one day (one surgical setting)
- Likely to follow-up with surgeon until fracture is healed
- Ability to understand and agree to Informed Consent
Who cannot join
- Under 18 years old or over 85 years old
- Open fracture(s)
- Fracture requires multiple operations
- Other injuries requiring operations
- Documented allergy to Cefazolin or Vancomycin
- Previous history of Methicillin-resistant Staphylococcus aureus infection
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- Previous surgery on the injured extremity within 1 year
- Use of antibiotics within 2 weeks before or after injury
- Use of antibiotics within 2 weeks before surgery
- Unlikely to follow-up until fracture is healed
- Unable to understand and agree to Informed Consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Erlanger Health System
Chattanooga, Tennessee, 37403
About this study
Official title: Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin
The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period.
The hypothesis of this study is that patients undergoing surgical treatment for closed fractures who are treated prophylactically with Vancomycin will have a lower incidence rate of infection than patients who are treated prophylactically with Cefazolin.
- Conditions
- Infection, Closed Fractures
- Being tested
- Cefazolin, Vancomycin
- Medical subject headings
- Infections, Fractures, Closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
VancomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Active comparator | intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively Receives: Drug: Cefazolin |
| Vancomycin | Active comparator | intravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of infection
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startOct 2009
- Primary completionJun 2015
- Study completionDec 2017
Why it stopped: Could not complete study due to administrative challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J Nowotarski, M.D., Principal investigator, UTCOM Chattanooga/Erlanger Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027532
- Sponsor's protocol ID
- 09-060
- Status last verified
- May 2017
- First submitted
- 2 Jan 2014
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Infection in Surgical Treatment of Closed Fractures: A Comparative Study of Cefazolin Versus Vancomycin
- ClinicalTrials.gov ID
- NCT02027532
- Acronym / sponsor ID
- 09-060
- Conditions
- Infection, Closed Fractures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not complete study due to administrative challenges
- Enrolment
- 430 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Jan 2014 (estimated)
- 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.
The purpose of this study is to compare the incidence rate of infection in surgical patients with closed fractures treated prophylactically with Cefazolin versus Vancomycin in the peri-operative period.
The hypothesis of this study is that patients undergoing surgical treatment for closed fractures who are treated prophylactically with Vancomycin will have a lower incidence rate of infection than patients who are treated prophylactically with Cefazolin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Active comparator | Drug: Cefazolinintravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively |
| Vancomycin | Active comparator | Drug: Vancomycinintravenous, weight-based dose (1gm<80kg, 2gm>80kg), perioperatively |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 18 years old and 85 years old
- Closed fracture
- Fracture treatment plan is for one operation on one day (one surgical setting)
- Likely to follow-up with surgeon until fracture is healed
- Ability to understand and agree to Informed Consent
Key exclusion criteria (11 listed)
- Under 18 years old or over 85 years old
- Open fracture(s)
- Fracture requires multiple operations
- Other injuries requiring operations
- Documented allergy to Cefazolin or Vancomycin
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 |
|---|---|---|
| Cefazolin | Drug | Cefazolin |
| Vancomycin | Drug | Vancomycin |
Primary outcome
incidence of infection
Time frame: one year
Results and safety
The study was stopped early (reason given: Could not complete study due to administrative challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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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.
Peter J Nowotarski, M.D. principal investigator
UTCOM Chattanooga/Erlanger Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin and Vancomycin in people with Infection and Closed Fractures, run by University of Tennessee at 1 site in United States.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 stopped early (reason given: Could not complete study due to administrative challenges). Results are not available in the source record.
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?
incidence of infection (time frame: one year). 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 11 Jul 2018.