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A dye that lights up blood flow may help surgeons save limbs and prevent infection

NCT ID NCT04416412

Diagnosis 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

After a severe open fracture, surgeons must remove dead or damaged tissue to prevent infection, but it can be hard to tell what is healthy. This study tests whether injecting a fluorescent dye (ICG) and using a special camera during surgery can show blood flow in real time, helping guide the cleaning. Researchers will follow 124 adults with open leg or arm fractures to see if the imaging is linked to fewer infections or unplanned repeat surgeries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
indocyanine green (ICG) dye injected intravenously and imaged with a near-infrared surgical microscope
What this could lead to
If it works, this imaging technique could help surgeons remove only the truly damaged tissue, potentially reducing infections and repeat surgeries.
What could go wrong
This is an early observational study, so it will only show whether the imaging is linked to outcomes, not prove it improves them. The dye and camera are already approved for other uses, but their value in trauma is unproven.

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

124 people

The number who actually took part.

Started

Oct 2020

Finished

Jul 2026

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 an open fracture will be considered for the open fracture cohort.

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: 1. Patients 18 years of age or older. 2. Open extremity fracture. 3. Planned definitive fracture management with external fixation, internal fixation, or joint fusion. 4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury. 5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate. 6. Provision of informed consent. Exclusion Criteria: 1. Inability of patient to provide informed consent 2. Fracture of the hand. 3. Iodine allergy. 4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic. 5. Open fracture managed outside of the participating orthopaedic service. 6. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery. 7. Burns at the fracture site.

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Conditions

The condition(s) this trial relates to.

Accidental Injuries Fractures, Open 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, 021115, 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. Cowley Shock Trauma

    Baltimore, Maryland, 21201, United States

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