AutoMated BUrn Diagnostic System for Healthcare (AMBUSH) (AMBUSH)
AutoMated Burn Diagnostic System for Healthcare
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Jen Lehman, RN
- Phone Number: 3172787312
- Email: jgeck@iu.edu
Study Contact Backup
- Name: Amy Miller, MA
- Email: amym@iu.edu
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Eskenazi Health
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Subjects must meet all the following enrollment criteria to be eligible for participation in the study:
- Male or female patients aged 18 years and above.
- The patient has a thermal burn injury
- Antibiotic use allowed
- Patient does not need to have the ability to communicate
- Inpatient or outpatient
- Within 7 days of burn
- No prior surgical debridement
- Burn ≤ 75% of body surface
- The patient or their legal representative agrees to comply with all compulsory study procedures and visit schedule
- The patient or their legal representative agrees to abstain from enrollment in any other clinical trial for the duration of the study.
In the opinion of the investigator, the patient or their legal representative must be able to:
- Understand the full nature and purpose of the study, including possible risks and adverse events,
- Understand instruction, and
- Provide voluntary informed written consent/assent as appropriate for study participation.
Exclusion Criteria: Subjects who meet any of the following criteria are not eligible for participation in the study:
- Unable to provide informed consent
- Age <18 years
- Burn ≥ 75% of body surface
- Burns caused by chemicals, electricity or radiation.
- Patients presenting with only 3rd-degree/full-thickness wounds which require immediate autografting.
- Burn injury has had prior surgical treatment.
- Prisoners
- Pregnant individuals
- Unable to follow study schedule or understand study instructions
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compare human assessment of burn depth to AI assessment
Time Frame: 2 year
|
Compare human assessment of burn depth to the technology output (Artificial Intelligence and TDI) as determined by need for surgery (time points include day 0 +/- 3 days).
Biopsy collected from patients that go to OR (one-time collection) to verify the burn depth via histological analysis.
|
2 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confirm burn conversion
Time Frame: 2 years
|
: Confirm burn conversion by the presence of infection as found in the electronic medical record (EMR).
Confirm burn infection by sending one tissue biopsy from OR (one-time collection)
|
2 years
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate burn software accuracy
Time Frame: 2 yrs
|
Survey software evaluators - who are medical providers, residents, and medical students.
The tertiary aim will be designed and conducted after the primary and secondary aims have completed, and that the protocol will be amended to include this design and all necessary elements at that time.
The tertiary aim was presented to show how additional validity surrounding the ease of use and understanding of results produced by the program in real life situations will be established.
|
2 yrs
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Gayle Gordillo, MD, Indiana University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 12689
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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