Wound Perfusion in High Risk Surgical Incisions
Primary Purpose
Bone Fractures Multiple
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telethermographic images
Sponsored by
About this trial
This is an interventional diagnostic trial for Bone Fractures Multiple focused on measuring perfusion
Eligibility Criteria
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:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Wound photographs
Arm Description
Telethermographic photographs of fracture wound and contralateral limb before and after propofol infusion.
Outcomes
Primary Outcome Measures
Soft tissue healing
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Soft tissue healing
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Soft tissue healing
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Soft tissue healing
The number of patients with the expected level of incision healing appropriate to the time frame per Clinician judgement
Secondary Outcome Measures
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
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
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
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
Full Information
NCT ID
NCT04233307
First Posted
January 15, 2020
Last Updated
January 16, 2020
Sponsor
Florida Orthopaedic Institute
1. Study Identification
Unique Protocol Identification Number
NCT04233307
Brief Title
Wound Perfusion in High Risk Surgical Incisions
Official Title
Non-invasive Assessment of Perfusion and the Risk of Wound Complication in High Risk Surgical Incisions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida Orthopaedic Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fractures Multiple
Keywords
perfusion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wound photographs
Arm Type
Other
Arm Description
Telethermographic photographs of fracture wound and contralateral limb before and after propofol infusion.
Intervention Type
Diagnostic Test
Intervention Name(s)
Telethermographic images
Other Intervention Name(s)
Forward-Looking Infrared (FLIR) photographs
Intervention Description
Infrared digital thermography photographs of fracture wound and contralateral limb before and after propofol infusion.
Primary Outcome Measure Information:
Title
Soft tissue healing
Description
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
Title
Soft tissue healing
Description
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
Title
Soft tissue healing
Description
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
Title
Soft tissue healing
Description
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 Outcome Measure Information:
Title
Additional wound care intervention needed
Description
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
Title
Additional wound care intervention needed
Description
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
Title
Additional wound care intervention needed
Description
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
Title
Additional wound care intervention needed
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Steverson, MHA
Phone
8132532068
Email
bsteverson@floridaortho.com
First Name & Middle Initial & Last Name or Official Title & Degree
Randi Alexander, MPH
Phone
8132532068
Email
ralexander@floridaortho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Mir, MD
Organizational Affiliation
Florida Orthopaedic Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Wound Perfusion in High Risk Surgical Incisions
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