Open FractureNCT02948387
Preventing Infections in Orthopaedic Patients
An observational study of Open Fracture, run by Olayemi Osiyemi MD at 1 site in United States.
Trial summary
Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Fracture
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Feb 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are at least 18 years of age with Type II or III open fractures
Who may be able to join
- Male or Female >= 18 years old
- Patients are diagnosed with a Type II or III open fracture
Who cannot join
- Prior to treatment, report of an allergy to beta-lactam or aminoglycoside antibiotics
- pregnancy
- did not receive 72 hours of IV antibiotic prophylaxis with 1st or 2nd generation cephalosporin and either gentamicin or tobramycin
- receiving ongoing inpatient care
Trial locations and contacts
1 site in 1 country.
United States1 site
Triple O Research Institute PA
West Palm Beach, Florida, 33401
About this study
Official title: Antibiotic Prophylaxis for Type II and III Open Fractures: a Retrospective Chart Review
Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective.
Read the detailed description
- Determine the safety and efficacy of antibiotic prophylaxis in type II and II open fractures when using IV Cephalosporin and aminoglycoside.
- Identify the incidence of acute kidney injury.
- Identify the type and number of associated infections
- Identify the antibiotic resistance profile noted
- Identify any secondary infections at sites other than the fracture site
- Conditions
- Open Fracture
- Medical subject headings
- Fractures, Open
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fracture site infections
number of infections
Measured: 30 days
Secondary outcomes (4)
Incidence of acute renal injury
number of patients with worsening renal function from baseline
Measured: 30 days
type of bacteria infection
name of bacteria infection
Measured: 30 days
resistance trend in patients with infections
describe the number of MDRO infections
Measured: 30 days
number of secondary infections at site other than fracture sites
describe the number infections at secondary sites
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open FractureStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olayemi Osiyemi MD
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor-investigator, Olayemi Osiyemi MD, Triple O Research Institute PA
- Investigators
- Olayemi Osiyemi, MD, Principal investigator, Triple O Research Institute PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948387
- Sponsor's protocol ID
- TEF-IT-40A
- Status last verified
- Oct 2016
- First submitted
- 14 Oct 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Type II and III Open Fractures: a Retrospective Chart Review
- ClinicalTrials.gov ID
- NCT02948387
- Acronym / sponsor ID
- TEF-IT-40A
- Conditions
- Open Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Olayemi Osiyemi MDUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 28 Oct 2016 (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.
Determine if antibiotic prophylaxis with intravenous cephalosporin and aminoglycoside in patients with Type II and II open fractures is safe and effective.
Detailed description
- Determine the safety and efficacy of antibiotic prophylaxis in type II and II open fractures when using IV Cephalosporin and aminoglycoside.
- Identify the incidence of acute kidney injury.
- Identify the type and number of associated infections
- Identify the antibiotic resistance profile noted
- Identify any secondary infections at sites other than the fracture site
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are at least 18 years of age with Type II or III open fractures
Key inclusion criteria (2 listed)
- Male or Female >= 18 years old
- Patients are diagnosed with a Type II or III open fracture
Key exclusion criteria (4 listed)
- Prior to treatment, report of an allergy to beta-lactam or aminoglycoside antibiotics
- pregnancy
- did not receive 72 hours of IV antibiotic prophylaxis with 1st or 2nd generation cephalosporin and either gentamicin or tobramycin
- receiving ongoing inpatient care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of fracture site infections
Time frame: 30 days
number of infections
4 secondary outcomes
Incidence of acute renal injury
Time frame: 30 days
type of bacteria infection
Time frame: 30 days
resistance trend in patients with infections
Time frame: 30 days
number of secondary infections at site other than fracture sites
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
Olayemi Osiyemi, MD principal investigator
Triple O Research Institute PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Fracture, run by Olayemi Osiyemi MD 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Glickman (561-855-7871, pglickmn@tripleoresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fracture site infections (time frame: 30 days). 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 28 Oct 2016.