OCT in Open Fracture and Infected Fracture

July 21, 2026 updated by: Ida Leah Gitajn, Dartmouth-Hitchcock Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years of age or older who present to DHMC (Lebanon) with open and infected fracture

Description

Inclusion Criteria:

  • Age 18 years or older
  • Open fracture
  • Fracture Related Infection

Exclusion Criteria:

  • Metatarsal fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open Fracture
High energy open fracture.
Procedure: Open Fracture
Patients 18 years of age or older with open fracture. Provision of informed consent.
Infected Fracture
Infected open or closed fracture.
Procedure: Infected Fracture
Patients 18 years of age or older with infected fracture. Provision of informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

Dartmouth College

Investigators

  • Principal Investigator: Ida L Gitajn, Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02001786

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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