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临床试验/NCT06938061
NCT06938061终止不适用

Integrating 3D Imaging Technology for Precise Burn Wound Assessment

HealthPartners Institute1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2025年5月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Concordance between TBSA based on Clinician measurements and TBSA based on DermaMonitor Camera measurements

研究概览

简要总结

The goal of this prospective cohort study is to determine if the DermaMonitor camera can accurately determine burn size in patients with 1st, 2nd, or 3rd degree burns, with exploratory aim of testing a new Artificial Intelligence (AI) program for determining burn depth. The main aims are:

  1. The primary aim of this study is to assess an objective process for the classification of burn size using the DermaMonitor wound camera.
  2. An exploratory aim of this study is to begin to train an Artificial Intelligence (AI) program to classify burn depth (1st, 2nd, 3rd degree) using the 3D images from this novel wound camera.

Researchers will compare DermaMonitor size classification and AI depth classification to clinician determinations. Participants will have images taken of their burn. Participation ends when the images are taken.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults sustaining burns
  • •Outpatients
  • •No prior surgery on the wounds
  • •No known infection of the wounds

排除标准

  • •Burns to the face or sensitive areas (genitals)
  • •Burns located on or near identifying landmarks such as tattoos or birthmarks
  • •Non-English speaking patients
  • •Patients unable to sign their name
  • •Burn occurred greater than 7 days prior to clinic visit
  • •Age greater than 90 (Patient age is sent externally to IKO, to ensure no PHI is sent, patients with an age >90 will not be enrolled)

研究组 & 干预措施

1st Degree Burn

Patients presenting to Regions Hospital Burn Clinic with a 1st degree burn

干预措施: 3D Imaging (Device)

2nd Degree Burn

Patients presenting to Regions Hospital Burn Clinic with a 2nd degree burn

干预措施: 3D Imaging (Device)

3rd Degree Burn

Patients presenting to Regions Hospital Burn Clinic with a 3rd degree burn

干预措施: 3D Imaging (Device)

结局指标

主要结局

Concordance between TBSA based on Clinician measurements and TBSA based on DermaMonitor Camera measurements

时间窗: Through study completion, an average of one year

Measurements of the burn will be taken by clinicians in the burn clinic and translated into total burn surface area (TBSA) using body mass index and height. This will be compared to TBSA computed from measurements taken virtually using the DermaMonitor camera and the same body mass index and height values.

次要结局

  • Concordance between clinician burn depth determination (1st, 2nd, 3rd degree burn) and AI determination of burn depth based on DermaMonitor images(Through study completion, an average of one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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