Intraoperative Fluorescence AngiographyNCT05006313
Intraoperative Fluorescence Angiography in Debridement of Open Fractures
A study testing Intraoperative fluorescence angiography in people with Intraoperative Fluorescence Angiography, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The proposed research aims to be a pilot feasibility study to evaluate intraoperative fluorescence angiography (IFA) as an aid for acute debridement in orthopaedic trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Fluorescence Angiography
- What is being tested?
- Intraoperative fluorescence angiography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 28 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- All adults ≥18 years old
- Open type II or type III upper or lower extremity fracture to be treated at Vanderbilt University Medical Center with operative intervention by orthopaedic trauma or orthopaedic hand surgeons.
Who cannot join
- Patients <18 years old
- Pregnant
- In extremis or requiring expedited surgical care outside of standard treatment
- Allergy or medical contraindication to indocyanine green dye.
Trial locations and contacts
1 site in 1 country.
About this study
The proposed research aims to be a pilot feasibility study to evaluate intraoperative fluorescence angiography (IFA) as an aid for acute debridement in orthopaedic trauma.
Read the detailed description
The investigators will perform a prospective cohort study evaluating the utility of IFA in acute debridement of type II and type III open extremity fractures by testing the frequency that IFA leads to additional debridement of compromised tissue. The investigators will also identify the incidence of clinically important secondary outcomes for future evaluation in a multicenter randomized controlled trial. Secondary outcomes will include the occurrence of a secondary procedure for surgical debridement, the need for a soft tissue coverage procedure, and the incidence of post-operative wound complications. Additionally, the investigators will evaluate surgeon experience using IFA to understand ease of use and surgeon satisfaction.
At the conclusion of this study, the investigators will be able to understand how often IFA may assist surgeons perform successful debridement and potential advantages of use. IFA may improve debridement by identifying tissue that is not viable but difficult to assess by the current gold standard, clinical acumen, or by giving surgeons confidence that the debridement is adequate and that the wound may be safely closed. Ultimately, IFA may prove to reduce the need for further procedures and potentially reduce the post-operative infection rate.
Aim 1: Evaluate the frequency that IFA leads to the debridement of additional tissue during the same operative procedure for type II and type III open extremity fractures following an initial debridement using clinical measures of tissue viability.
Hypothesis: Adult patients (≥18 years old) undergoing surgical debridement of an upper or lower extremity type II or type III open fracture will have additional tissue debrided after use of IFA in at least 18% of cases, the frequency reported in plastic surgery literature.
- Patients will undergo a standard initial debridement by the treating surgeon. When the surgeon feels the debridement is complete, IFA will be performed.
- The amount and type of additional tissue debrided will be recorded. Percent perfusion on IFA imaging will be recorded for all tissue that requires additional debridement compared with a pre-selected reference.
Aim 2: Evaluate incidence of post-operative wound complications, repeat debridement, or soft tissue coverage after debridement is performed using IFA for type II and type III open extremity fractures.
Hypothesis: Adult patients (≥18 years old) undergoing surgical debridement of an upper or lower extremity type II or type III open fracture with the use of IFA will have a lower post-operative infection or dehiscence rate and require fewer procedures for repeat debridement or coverage compared to institutional standards.
- Patients will undergo a standard initial debridement by the treating surgeon. When the surgeon feels the debridement is complete, IFA will be performed.
- Post-operative surgical site infection requiring debridement or antibiotic treatment or wound dehiscence requiring wound care or surgery will be noted within 30-days from the initial debridement.
- The occurrence and number of repeat debridement procedures will be noted until definitive wound closure or reconstruction. The need for soft tissue coverage and type of coverage will be noted for each injury.
Aim 3: Evaluate surgeon experience using IFA for acute debridement of type II and type III open extremity fractures.
Hypothesis: Surgeons rate the use of IFA as easy and helpful. A) Patients will undergo a standard initial debridement by the treating surgeon. When the surgeon feels the debridement is complete, IFA will be performed.
- After surgery, surgeons will complete a surgeon assessment form assessing ease of use, if the surgeon felt IFA to be helpful, and overall satisfaction based on a Likert-type scale.
- Conditions
- Intraoperative Fluorescence Angiography
- Being tested
- Intraoperative fluorescence angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative fluorescence angiographyDevice
Intraoperative fluorescence angiography will be used to assess tissue perfusion following initial debridement of wound.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative fluorescence angiography | Experimental | Intraoperative fluorescence angiography will be utilized to view initial debridement area. Using a sterile marking pen, the surgeon will mark the areas of tissue on skin, subcutaneous tissue, muscle, bone, or other that he or she wishes to debride further due to poor perfusion. A reference point on uninjured tissue of the same extremity at least 10 cm from the wound will be identified and measured for perfusion (set to reference of 100% perfusion). The area to be further debrided will be measured for percent perfusion relative to this reference point. Receives: Device: Intraoperative fluorescence angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Additional debridement following IFA use
Yes/No
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Jul 2024
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Why it stopped: Study was withdrawn from the IRB before approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Fluorescence AngiographyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jed Maslow, Vanderbilt University Medical Center
- Investigators
- Jed I Maslow, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006313
- Sponsor's protocol ID
- 211499
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2021
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Fluorescence Angiography in Debridement of Open Fractures
- ClinicalTrials.gov ID
- NCT05006313
- Acronym / sponsor ID
- 211499
- Conditions
- Intraoperative Fluorescence Angiography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn from the IRB before approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 16 Aug 2021 (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.
The proposed research aims to be a pilot feasibility study to evaluate intraoperative fluorescence angiography (IFA) as an aid for acute debridement in orthopaedic trauma.
Detailed description
The investigators will perform a prospective cohort study evaluating the utility of IFA in acute debridement of type II and type III open extremity fractures by testing the frequency that IFA leads to additional debridement of compromised tissue. The investigators will also identify the incidence of clinically important secondary outcomes for future evaluation in a multicenter randomized controlled trial. Secondary outcomes will include the occurrence of a secondary procedure for surgical debridement, the need for a soft tissue coverage procedure, and the incidence of post-operative wound complications. Additionally, the investigators will evaluate surgeon experience using IFA to understand ease of use and surgeon satisfaction.
At the conclusion of this study, the investigators will be able to understand how often IFA may assist surgeons perform successful debridement and potential advantages of use. IFA may improve debridement by identifying tissue that is not viable but difficult to assess by the current gold standard, clinical acumen, or by giving surgeons confidence that the debridement is adequate and that the wound may be safely closed. Ultimately, IFA may prove to reduce the need for further procedures and potentially reduce the post-operative infection rate.
Aim 1: Evaluate the frequency that IFA leads to the debridement of additional tissue during the same operative procedure for type II and type III open extremity fractures following an initial debridement using clinical measures of tissue viability.
Hypothesis: Adult patients (≥18 years old) undergoing surgical debridement of an upper or lower extremity type II or type III open fracture will have additional tissue debrided after use of IFA in at least 18% of cases, the frequency reported in plastic surgery literature.
- Patients will undergo a standard initial debridement by the treating surgeon. When the surgeon feels the debridement is complete, IFA will be performed.
- The amount and type of additional tissue debrided will be recorded. Percent perfusion on IFA imaging will be recorded for all tissue that requires additional debridement compared with a pre-selected reference.
Aim 2: Evaluate incidence of post-operative wound complications, repeat debridement, or soft tissue coverage after debridement is performed using IFA for type II and type III open extremity fractures.
Hypothesis: Adult patients (≥18 years old) undergoing surgical debridement of an upper or lower extremity type II or type III open fracture with the use of IFA will have a lower post-operative infection or dehiscence rate and require fewer procedures for repeat debridement or coverage compared to institutional standards.
- Patients will undergo a standard initial debridement by the treating surgeon. When the surgeon feels the debridement is complete, IFA will be performed.
- Post-operative surgical site infection requiring debridement or antibiotic treatment or wound dehiscence requiring wound care or surgery will be noted within 30-days from the initial debridement.
- The occurrence and number of repeat debridement procedures will be noted until definitive wound closure or reconstruction. The need for soft tissue coverage and type of coverage will be noted for each injury.
Aim 3: Evaluate surgeon experience using IFA for acute debridement of type II and type III open extremity fractures.
Hypothesis: Surgeons rate the use of IFA as easy and helpful. A) Patients will undergo a standard initial debridement by the treating surgeon. When the surgeon feels the debridement is complete, IFA will be performed.
- After surgery, surgeons will complete a surgeon assessment form assessing ease of use, if the surgeon felt IFA to be helpful, and overall satisfaction based on a Likert-type scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative fluorescence angiography | Experimental | Device: Intraoperative fluorescence angiographyIntraoperative fluorescence angiography will be utilized to view initial debridement area. Using a sterile marking pen, the surgeon will mark the areas of tissue on skin, subcutaneous tissue, muscle, bone, or other that he or she wishes to debride further due to poor perfusion. A reference point on uninjured tissue of the same extremity at least 10 cm from the wound will be identified and measured for perfusion (set to reference of 100% perfusion). The area to be further debrided will be measured for percent perfusion relative to this reference point. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adults ≥18 years old
- Open type II or type III upper or lower extremity fracture to be treated at Vanderbilt University Medical Center with operative intervention by orthopaedic trauma or orthopaedic hand surgeons.
Key exclusion criteria (4 listed)
- Patients <18 years old
- Pregnant
- In extremis or requiring expedited surgical care outside of standard treatment
- Allergy or medical contraindication to indocyanine green dye.
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 |
|---|---|---|
| Intraoperative fluorescence angiographyIntraoperative fluorescence angiography will be used to assess tissue perfusion following initial debridement of wound. | Device | Intraoperative fluorescence angiography |
Primary outcome
Additional debridement following IFA use
Time frame: Intraoperative
Yes/No
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jed I Maslow, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative fluorescence angiography in people with Intraoperative Fluorescence Angiography, run by Vanderbilt University 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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 22 Oct 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Additional debridement following IFA use (time frame: Intraoperative). 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 22 Oct 2024.