Bone Fractures MultipleNCT04233307
Wound Perfusion in High Risk Surgical Incisions
A study testing Telethermographic images in people with Bone Fractures Multiple, run by Florida Orthopaedic Institute.
Trial summary
This is a prospective cohort pilot study. The primary purpose is to report the perfusion status of the surgical field in at risk surgical incisions. The secondary purposes are to describe the relationship between perfusion status and wound healing status and complications, and to describe the relationship between… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Fractures Multiple
- What is being tested?
- Telethermographic images
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Dec 2021
- 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
- Skeletally mature patients, with talus, calcaneus, tibial plafond, trimalleolar ankle fracture-dislocations, lisfranc, or tibial plateau fractures who are indicated for surgical management in the form of open reduction and internal fixation or external fixation.
Who cannot join
- Pathologic Fracture
- Previous open surgery in the operative field
- Prisoners
- Systemic skin disorder affecting the surgical field
- Vascular Injury involving vessel that supplies the surgical field
- Bilateral qualifying lower extremity injuries
- Homeless
- Those unable to follow up through the study period
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Non-invasive Assessment of Perfusion and the Risk of Wound Complication in High Risk Surgical Incisions
This is a prospective cohort pilot study. The primary purpose is to report the perfusion status of the surgical field in at risk surgical incisions. The secondary purposes are to describe the relationship between perfusion status and wound healing status and complications, and to describe the relationship between infrared digital thermography perfusion readings and the timing of propofol infusion. The research intervention will be photographs taken of the wound on the injured extremity, with a Forward-Looking Infrared (FLIR) camera, for the purpose of assessing perfusion status and skin temperature at the surgical site.
Read the detailed description
Patients with qualifying injuries will be identified at the time of injury. There will be no deviation from standard of care for these patients outside of the acquisition of the FLIR image. Standard emergent management of these injuries including but not limited to reduction, immobilization, and acquisition of advanced imaging will take place. Pre-operative discussion of the risks and benefits of surgical management will occur and informed consent obtained.
Propofol is a commonly used anesthetic agent. However, propofol is also a vasodilating agent, which acts by blocking sympathetic tone. Limited worked has been done to evaluate the effects of propofol administration on the FLIR imaging data acquisition. A single study used FLIR to look at tissue perfusion after propofol infusion in children. In this study, the primary concern was whether infrared imaging could replace or augment, serial blood pressure and heart rate measurements, or other invasive monitoring measurements in patients undergoing general anesthesia with the use of vasodilatory agents, such as propofol. The authors' goal was to "assess the ability of the thermal imager to trend heat loss that registers as skin temperature from propofol-mediated vasodilation and study reversibility as propofol levels drop and vascular tone returns." This leaves a void regarding surgeons' understanding of the optimal timing of FLIR perfusion assessment and the reliability of measurements obtained pre and post propofol infusion.
In order to better understand the effects of propofol and determine the optimal time for determining perfusion with the FLIR camera, the investigators will take a first reading in the pre-operative holding area, prior to the administration of any propofol or other vaso-active agent (as described below). Once in the operating room, after the induction of anesthesia but prior to application of any topical cleansing or cooling products to the skin, the participant will be transferred to the operating room table and placed on a clean, white sheet and blankets will be removed from both lower extremities. The planned surgical incision(s) to be used will be drawn on the skin by the most senior surgeon. Next, a clinical photo and a FLIR image will be obtained at 90 degrees to the skin, and 1 meter from the surface of the skin at the site of each planned incision. One researcher has successfully used a protocol of taking images at perpendicular to the skin and 1 meter distance and demonstrated that deviation of as much as 20 degrees from the perpendicular and 0.5m of distance has negligible effect on readings. A set of control photos, identical to the ones obtained on the injured extremity will be obtained on the contralateral, non-injured extremity. A physician who is part of the surgical team who is trained in the use of the FLIR camera will obtain the images. At the time of image acquisition, results of the wrinkle test at each incision, patient body temperature, room temperature and humidity will be recorded. Analysis of the FLIR images will involve averaging the tissue perfusion in a box drawn with 1 cm borders around the planned incision site as well as the entire area imaged. This will be compared to the control, the contralateral uninjured extremity.
Participants will receive standard operative management of these injuries with standard of care post-operative management.
- Conditions
- Bone Fractures Multiple
- Being tested
- Telethermographic images
- Keywords
- perfusion
- Medical subject headings
- Fractures, Multiple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telethermographic imagesDiagnostic test
Also called Forward-Looking Infrared (FLIR) photographs
Infrared digital thermography photographs of fracture wound and contralateral limb before and after propofol infusion.
| Study group | Role | What they receive |
|---|---|---|
| Wound photographs | Other | Telethermographic photographs of fracture wound and contralateral limb before and after propofol infusion. Receives: Diagnostic Test: Telethermographic images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue healing
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Measured: 2 weeks post-operative
Soft tissue healing
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Measured: 6 weeks post-operative
Soft tissue healing
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Measured: 3 months post-operative
Soft tissue healing
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Measured: 6 months post-operative
Secondary outcomes (4)
Additional wound care intervention needed
The number of participants requiring topical wound care, oral antibiotics, repeat surgical debridement, soft tissue coverage procedure or amputation required
Measured: within the 2 week post-operative period
Additional wound care intervention needed
The number of participants requiring topical wound care, oral antibiotics, repeat surgical debridement, soft tissue coverage procedure or amputation required
Measured: within the 6 week post-operative period
Additional wound care intervention needed
The number of participants requiring topical wound care, oral antibiotics, repeat surgical debridement, soft tissue coverage procedure or amputation required
Measured: within the 3 month post-operative period
Additional wound care intervention needed
The number of participants requiring topical wound care, oral antibiotics, repeat surgical debridement, soft tissue coverage procedure or amputation required
Measured: within the 6 month post-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study startFeb 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Fractures MultipleStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Orthopaedic Institute
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Barbara Steverson, Florida Orthopaedic Institute
- Investigators
- Hassan Mir, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233307
- Sponsor's protocol ID
- USF000305
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of Perfusion and the Risk of Wound Complication in High Risk Surgical Incisions
- ClinicalTrials.gov ID
- NCT04233307
- Acronym / sponsor ID
- USF000305
- Conditions
- Bone Fractures Multiple
- Keywords
- perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Florida Orthopaedic InstituteResearch network
- Study start
- Feb 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Jan 2020 (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.
This is a prospective cohort pilot study. The primary purpose is to report the perfusion status of the surgical field in at risk surgical incisions. The secondary purposes are to describe the relationship between perfusion status and wound healing status and complications, and to describe the relationship between infrared digital thermography perfusion readings and the timing of propofol infusion. The research intervention will be photographs taken of the wound on the injured extremity, with a Forward-Looking Infrared (FLIR) camera, for the purpose of assessing perfusion status and skin temperature at the surgical site.
Detailed description
Patients with qualifying injuries will be identified at the time of injury. There will be no deviation from standard of care for these patients outside of the acquisition of the FLIR image. Standard emergent management of these injuries including but not limited to reduction, immobilization, and acquisition of advanced imaging will take place. Pre-operative discussion of the risks and benefits of surgical management will occur and informed consent obtained.
Propofol is a commonly used anesthetic agent. However, propofol is also a vasodilating agent, which acts by blocking sympathetic tone. Limited worked has been done to evaluate the effects of propofol administration on the FLIR imaging data acquisition. A single study used FLIR to look at tissue perfusion after propofol infusion in children. In this study, the primary concern was whether infrared imaging could replace or augment, serial blood pressure and heart rate measurements, or other invasive monitoring measurements in patients undergoing general anesthesia with the use of vasodilatory agents, such as propofol. The authors' goal was to "assess the ability of the thermal imager to trend heat loss that registers as skin temperature from propofol-mediated vasodilation and study reversibility as propofol levels drop and vascular tone returns." This leaves a void regarding surgeons' understanding of the optimal timing of FLIR perfusion assessment and the reliability of measurements obtained pre and post propofol infusion.
In order to better understand the effects of propofol and determine the optimal time for determining perfusion with the FLIR camera, the investigators will take a first reading in the pre-operative holding area, prior to the administration of any propofol or other vaso-active agent (as described below). Once in the operating room, after the induction of anesthesia but prior to application of any topical cleansing or cooling products to the skin, the participant will be transferred to the operating room table and placed on a clean, white sheet and blankets will be removed from both lower extremities. The planned surgical incision(s) to be used will be drawn on the skin by the most senior surgeon. Next, a clinical photo and a FLIR image will be obtained at 90 degrees to the skin, and 1 meter from the surface of the skin at the site of each planned incision. One researcher has successfully used a protocol of taking images at perpendicular to the skin and 1 meter distance and demonstrated that deviation of as much as 20 degrees from the perpendicular and 0.5m of distance has negligible effect on readings. A set of control photos, identical to the ones obtained on the injured extremity will be obtained on the contralateral, non-injured extremity. A physician who is part of the surgical team who is trained in the use of the FLIR camera will obtain the images. At the time of image acquisition, results of the wrinkle test at each incision, patient body temperature, room temperature and humidity will be recorded. Analysis of the FLIR images will involve averaging the tissue perfusion in a box drawn with 1 cm borders around the planned incision site as well as the entire area imaged. This will be compared to the control, the contralateral uninjured extremity.
Participants will receive standard operative management of these injuries with standard of care post-operative management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Wound photographs | Other | Diagnostic Test: Telethermographic imagesTelethermographic photographs of fracture wound and contralateral limb before and after propofol infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Skeletally mature patients, with talus, calcaneus, tibial plafond, trimalleolar ankle fracture-dislocations, lisfranc, or tibial plateau fractures who are indicated for surgical management in the form of open reduction and internal fixation or external fixation.
Key exclusion criteria (8 listed)
- Pathologic Fracture
- Previous open surgery in the operative field
- Prisoners
- Systemic skin disorder affecting the surgical field
- Vascular Injury involving vessel that supplies the surgical field
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 |
|---|---|---|
| Telethermographic imagesAlso: Forward-Looking Infrared (FLIR) photographsInfrared digital thermography photographs of fracture wound and contralateral limb before and after propofol infusion. | Diagnostic test | Wound photographs |
Primary outcome
Soft tissue healing
Time frame: 2 weeks post-operative
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Soft tissue healing
Time frame: 6 weeks post-operative
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Soft tissue healing
Time frame: 3 months post-operative
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Soft tissue healing
Time frame: 6 months post-operative
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
4 secondary outcomes
Additional wound care intervention needed
Time frame: within the 2 week post-operative period
Additional wound care intervention needed
Time frame: within the 6 week post-operative period
Additional wound care intervention needed
Time frame: within the 3 month post-operative period
Additional wound care intervention needed
Time frame: within the 6 month post-operative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- 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.
Hassan Mir, MD principal investigator
Florida Orthopaedic Institute
Questions about this trial
What is this clinical trial studying?
A study testing Telethermographic images in people with Bone Fractures Multiple, run by Florida Orthopaedic Institute.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Steverson, MHA (8132532068, bsteverson@floridaortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue healing (time frame: 2 weeks post-operative). The study lists 4 primary outcomes in all. 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 21 Jan 2020.