search
Back to results

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
Florida Orthopaedic Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Fractures Multiple focused on measuring perfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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

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

    First Posted
    January 15, 2020
    Last Updated
    January 16, 2020
    Sponsor
    Florida Orthopaedic Institute
    search

    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

    Learn more about this trial

    Wound Perfusion in High Risk Surgical Incisions

    We'll reach out to this number within 24 hrs