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Glowing dye could predict bone infections after fractures

NCT ID NCT04403204

Knowledge-focused Sponsor: Dartmouth-Hitchcock Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new way to measure blood flow in broken bones using a safe dye and a special camera. Researchers followed 104 fracture patients to see if poor blood flow leads to infections or other complications. The goal was to learn how to better predict and treat bone infections after injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

104 people

The number who actually took part.

Started

Sep 2020

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients 18 years of age or older who present with SSI following fracture or joint fusion Established SSI fracture cohort (Cohort 1). A subset of Cohort 1 will be considered for the Subset DCE-MRI cohort (Cohort 1-1).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Established SSI Fracture (Cohort Cohort 1, Group 1) 1. Patients 18 years of age or older. 2. Extremity fracture. 3. Prior definitive fracture management with external fixation, internal fixation, or joint fusion. 4. Superficial, deep, or organ space SSI (as per CDC criteria) at the fracture site that requires operative management. 5. Will have all fracture care surgeries performed by a participating surgeon or delegate. 6. Provision of informed consent. Subset: DCE-MRI (Cohort 1-1, Group 2) 1. Patients 18 years of age or older. 2. Closed extremity fracture. 3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion. 4. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. 5. Provision of informed consent. Exclusion Criteria: Established SSI Fracture Cohort (Cohort 1, Group 1) 1. Fracture of the hand. 2. Iodine allergy. 3. Received previous surgical debridement to manage the SSI. 4. Incarceration. 5. Problems, in the judgment of study personnel, with maintaining follow-up with the patient. Subset: DCE-MRI (Cohort 1-1, Group2) 6. the presence of an electronic implant, such as a pacemaker 7. the presence of a metal implant, such as an aneurysm clip 8. the presence of other contraindication(s), as determined by the MRI technologists and radiologists. 9. A history of allergy to iodides 10. A GFR \< 30 ml/min as determined by blood test on the day of NIR/MR imaging, or from lab results within 3 months of DCE-MRI for this study

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Conditions

The condition(s) this trial relates to.

Accidental Injuries bone fracture Infections injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Trauma injury

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • University of California, Irvine

    Irvine, California, 92614, United States

  • University of Maryland, Baltimore R. Adams Cowley Shock Trauma

    Baltimore, Maryland, 21201, United States

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