NCT04233307

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

January 15, 2020

Last Update Submit

January 16, 2020

Conditions

Bone Fractures Multiple

Keywords

perfusion

Outcome Measures

Primary Outcomes (4)

  • Soft tissue healing

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

    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

    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

    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

    6 months post-operative

Secondary Outcomes (4)

  • Additional wound care intervention needed

    within the 2 week post-operative period

  • Additional wound care intervention needed

    within the 6 week post-operative period

  • Additional wound care intervention needed

    within the 3 month post-operative period

  • Additional wound care intervention needed

    within the 6 month post-operative period

Study Arms (1)

Wound photographs

OTHER

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

Diagnostic Test: Telethermographic images

Interventions

Telethermographic imagesDIAGNOSTIC_TEST

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fractures, Multiple

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesMultiple Trauma

Study Officials

  • Hassan Mir, MD

    Florida Orthopaedic Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Steverson, MHA

CONTACT

8132532068bsteverson@floridaortho.com

Randi Alexander, MPH

CONTACT

8132532068ralexander@floridaortho.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort study
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Orthopaedic Trauma Service

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 18, 2020

Study Start

February 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

January 21, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share