InfectionNCT03064009
Regional and Seasonal Variations in the Incidence and Causative Organisms for Post-traumatic Wound Infections and Osteomyelitis After Open Fractures
An observational study of Infection, run by University of Washington at 2 sites in United States.
Trial summary
To determine if there is a relationship between people with open fractures and the season and location of where the injury occurred and the infections they develop Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Infection
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2017to 29 May 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Open fracture
Who may be able to join
- Open Fracture treated surgically between distal radius and distal tibia
- -
Who cannot join
- GSW Unable to follow for one year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harborview Medical Center
Seattle, Washington, 98104
Tampa General Hospital
Tampa, Florida, 33606
About this study
To determine if there is a relationship between people with open fractures and the season and location of where the injury occurred and the infections they develop
- Conditions
- Infection
- Being tested
- Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfectionOther
This is an observational trial
| Study group | Role | What they receive |
|---|---|---|
| Open Fractures | Patients with Open fractures between the distal radius and the distal tibia Receives: Other: Infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
Infection of the open fracture
Measured: One year after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Feb 2017
- Primary completion29 May 2018
- Study completion29 May 2018
Why it stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claude Sagi, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064009
- Sponsor's protocol ID
- 51835-ED
- Status last verified
- May 2018
- First submitted
- 22 Feb 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sagi HC, Donohue D, Cooper S, Barei DP, Siebler J, Archdeacon MT, Sciadini M, Romeo M, Bergin PF, Higgins T, Mir H; Center for Bone and Joint Infection. Institutional and Seasonal Variations in the Incidence and Causative Organisms for Posttraumatic Infection following Open Fractures. J Orthop Trauma. 2017 Feb;31(2):78-84. doi: 10.1097/BOT.0000000000000730.
PubMed 27755339
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional and Seasonal Variations in the Incidence and Causative Organisms for Post-traumatic Wound Infections and Osteomyelitis After Open Fractures
- ClinicalTrials.gov ID
- NCT03064009
- Acronym / sponsor ID
- 51835-ED
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 24 Feb 2017 (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.
To determine if there is a relationship between people with open fractures and the season and location of where the injury occurred and the infections they develop
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Fractures | – | Other: InfectionPatients with Open fractures between the distal radius and the distal tibia |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Open fracture
Key inclusion criteria (2 listed)
- Open Fracture treated surgically between distal radius and distal tibia
- -
Key exclusion criteria (1 listed)
- GSW Unable to follow for one year
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 |
|---|---|---|
| InfectionThis is an observational trial | Other | Open Fractures |
Primary outcome
Infection
Time frame: One year after injury
Infection of the open fracture
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Results publication: PubMed 27755339Sagi HC, Donohue D, Cooper S, Barei DP, Siebler J, Archdeacon MT, Sciadini M, Romeo M, Bergin PF, Higgins T, Mir H; Center for Bone and Joint Infection. Institutional and Seasonal Variations in the Incidence and Causative Organisms for Posttraumatic Infection following Open Fractures. J Orthop Trauma. 2017 Feb;31(2):78-84. doi: 10.1097/BOT.0000000000000730.
- Individual participant dataSharing planned: No
Related trials for Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by University of Washington at 2 sites 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 1 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 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. Low enrollment and PI leaving institution). 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?
Infection (time frame: One year after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064009, which also lists 1 linked publication.
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 31 May 2018.