OCT in Open Fracture and Infected Fracture
Optical Coherence Tomography Imaging to Visualize Bacteria or Biofilm on Hardware, Bone and Soft Tissue in Open Fracture and Infected Fracture
1 other identifier
observational
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
March 27, 2023
CompletedStudy Start
First participant enrolled
March 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
June 27, 2025
June 1, 2025
3.2 years
March 14, 2023
June 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
36 months
Study Arms (2)
Open Fracture
High energy open fracture.
Infected Fracture
Infected open or closed fracture.
Interventions
Patients 18 years of age or older with open fracture. Provision of informed consent.
Patients 18 years of age or older with infected fracture. Provision of informed consent.
Eligibility Criteria
Patients 18 years of age or older who present to DHMC (Lebanon) with open and infected fracture
You may qualify if:
- Age 18 years or older
- Open fracture
- Fracture Related Infection
You may not qualify if:
- Metatarsal fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dartmouth-Hitchcock Medical Centerlead
- Dartmouth Collegecollaborator
Study Sites (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ida L Gitajn
Dartmouth-Hitchcock Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Section Chief, Orthopaedics
Study Record Dates
First Submitted
March 14, 2023
First Posted
March 27, 2023
Study Start
March 27, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
June 27, 2025
Record last verified: 2025-06