ClinicalTrials.gg
Status unknownNCT04233307Updated Jan 21, 2020

Wound Perfusion in High Risk Surgical Incisions

An interventional study of Telethermographic images in Bone Fractures Multiple, sponsored by Florida Orthopaedic Institute. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-21.

Sponsored by Florida Orthopaedic Institute · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Bone Fractures Multiple

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Keywords

  • perfusion
03

In context

Fractures, Multiple

14 studies on the registry are indexed under Fractures, Multiple; 4 are open to participants now.

Browse Fractures, Multiple studies →

Lead sponsor

Florida Orthopaedic Institute is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  1. Pathologic Fracture
  2. Previous open surgery in the operative field
  3. Prisoners
  4. Systemic skin disorder affecting the surgical field
  5. Vascular Injury involving vessel that supplies the surgical field
  6. Bilateral qualifying lower extremity injuries
  7. Homeless
  8. Those unable to follow up through the study period
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Wound photographs

    Telethermographic photographs of fracture wound and contralateral limb before and after propofol infusion.

    Diagnostic Test: Telethermographic images

Interventions

  • Diagnostic testTelethermographic images

    Infrared digital thermography photographs of fracture wound and contralateral limb before and after propofol infusion.

    Also known as: Forward-Looking Infrared (FLIR) photographs

06

What researchers measure

Primary outcomes

  1. Soft tissue healing

    The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement

    Time frame: 2 weeks post-operative

  2. Soft tissue healing

    The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement

    Time frame: 6 weeks post-operative

  3. Soft tissue healing

    The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement

    Time frame: 3 months post-operative

  4. Soft tissue healing

    The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement

    Time frame: 6 months post-operative

Secondary outcomes

  1. 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

    Time frame: within the 2 week post-operative period

  2. 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

    Time frame: within the 6 week post-operative period

  3. 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

    Time frame: within the 3 month post-operative period

  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

    Time frame: within the 6 month post-operative period

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2020; primary completion for Dec 2020, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2020
First posted
Jan 18, 2020
StartEst.
Feb 2020
Primary completionEst.
Dec 2020
CompletionEst.
Dec 2021
Last update
Jan 21, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04233307
Lead sponsor
Florida Orthopaedic Institute
Responsible party
Barbara Steverson (Director of Research, Orthopaedic Trauma Service, Florida Orthopaedic Institute) — Principal investigator
First posted
Jan 18, 2020
Start date
Feb 2020 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jan 21, 2020

Study contacts

Barbara Steverson, MHA
Contact
bsteverson@floridaortho.com
8132532068
Randi Alexander, MPH
Contact
ralexander@floridaortho.com
8132532068
Hassan Mir, MD
principal investigator · Florida Orthopaedic Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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