Trauma InjuryNCT05785182
OCT in Open Fracture and Infected Fracture
An observational study of Trauma Injury and Trauma, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This is a pilot prospective, observational study of patients with open or infected fracture evaluating the feasibility and acceptability of OCT, a light-based imaging modality that requires no drug or contrast agent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury, Trauma, Open Fracture
- What is being tested?
- Open Fracture and Infected Fracture
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients 18 years of age or older who present to DHMC (Lebanon) with open and infected fracture
Who may be able to join
- Age 18 years or older
- Open fracture
- Fracture Related Infection
Who cannot join
- Metatarsal fractures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Holly B Symonds, 603-653-9440, Holly.B.Symonds@hitchcock.org
Devin S Mullin, 603-650-6032, Devin.S.Mullin@hitchcock.org
About this study
Official title: Optical Coherence Tomography Imaging to Visualize Bacteria or Biofilm on Hardware, Bone and Soft Tissue in Open Fracture and Infected Fracture
This is a pilot prospective, observational study of patients with open or infected fracture evaluating the feasibility and acceptability of OCT, a light-based imaging modality that requires no drug or contrast agent.
- Conditions
- Trauma Injury, Trauma, Open Fracture, Fracture Infection
- Being tested
- Open Fracture, Infected Fracture
- Medical subject headings
- Accidental Injuries, Wounds and Injuries, Fractures, Open
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open FractureProcedure or surgery
Patients 18 years of age or older with open fracture. Provision of informed consent.
Infected FractureProcedure or surgery
Patients 18 years of age or older with infected fracture. Provision of informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Open Fracture | High energy open fracture. Receives: Procedure: Open Fracture | |
| Infected Fracture | Infected open or closed fracture. Receives: Procedure: Infected Fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of OCT imaging
The primary objective of this work is to demonstrate feasibility, acceptability, and preliminary effectiveness of Optical Coherence Tomography (OCT) to image bacteria and biofilm.
Data will be analyzed accordingly: The association between optical imaging parameters (particularly around biofilm and bacterial contamination) and (1) surgical wound severity and (2) development of infection or treatment failure for infection.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start27 Mar 2023
- Primary completion28 Jul 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Principal investigator, Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center
- Investigators
- Ida L Gitajn, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785182
- Sponsor's protocol ID
- STUDY02001786
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Imaging to Visualize Bacteria or Biofilm on Hardware, Bone and Soft Tissue in Open Fracture and Infected Fracture
- ClinicalTrials.gov ID
- NCT05785182
- Acronym / sponsor ID
- STUDY02001786
- Conditions
- Trauma Injury, Trauma, Open Fracture, Fracture Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Mar 2023 (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.
This is a pilot prospective, observational study of patients with open or infected fracture evaluating the feasibility and acceptability of OCT, a light-based imaging modality that requires no drug or contrast agent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Fracture | – | Procedure: Open FractureHigh energy open fracture. |
| Infected Fracture | – | Procedure: Infected FractureInfected open or closed fracture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age or older who present to DHMC (Lebanon) with open and infected fracture
Key inclusion criteria (3 listed)
- Age 18 years or older
- Open fracture
- Fracture Related Infection
Key exclusion criteria (1 listed)
- Metatarsal fractures
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 |
|---|---|---|
| Open FracturePatients 18 years of age or older with open fracture. Provision of informed consent. | Procedure or surgery | Open Fracture |
| Infected FracturePatients 18 years of age or older with infected fracture. Provision of informed consent. | Procedure or surgery | Infected Fracture |
Primary outcome
Feasibility and acceptability of OCT imaging
Time frame: 36 months
The primary objective of this work is to demonstrate feasibility, acceptability, and preliminary effectiveness of Optical Coherence Tomography (OCT) to image bacteria and biofilm. Data will be analyzed accordingly: The association between optical imaging parameters (particularly around biofilm and bacterial contamination) and (1) surgical wound severity and (2) development of infection or treatment failure for infection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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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.
Ida L Gitajn principal investigator
Dartmouth-Hitchcock Medical Center
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 Trauma Injury and Trauma, run by Dartmouth-Hitchcock Medical Center 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 3 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly B Symonds (603-653-9440, Holly.B.Symonds@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of OCT imaging (time frame: 36 months). 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 2 Oct 2026.