Health Condition 1: T148- Other injury of unspecified body region
Conditions
Interventions
Intervention1: Robotic depth camera based wound assessment: Non contact wound imaging using a teleoperated robotic arm carrying a close range three dimensional depth camera positioned above the wound.
Sponsors
Mandya Institute of Medical Science MIMS
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged ten years and above with surface wounds or minor soft tissue trauma such as abrasions, lacerations, sutured wounds or postoperative surface wounds that can be safely exposed for imaging. Patients must be haemodynamically stable at the time of assessment. Written informed consent will be obtained from the patient or from a parent or legally authorised representative in case of minors, with assent from the child wherever appropriate.
Exclusion criteria
Exclusion criteria: Life threatening trauma or deep internal injuries requiring immediate emergency surgery. Wounds with heavy active bleeding, extensive necrosis or gross infection where imaging could delay treatment. Large area burns or wounds where adequate exposure for imaging is not possible. Known pregnant women are excluded because pregnancy is considered a vulnerable condition and this initial feasibility study does not specifically evaluate risks or benefits in pregnant patients. Patients who are unable or unwilling to provide written informed consent are also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of the automated machine learning based wound assessment system for estimating wound length, width and maximum depth compared with manual surgeon measurements, expressed as mean absolute difference in millimetres and percentage error for each parameter.Timepoint: Day 0 at baseline wound imaging during the single study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of wounds in which automated machine learning based measurements of wound length and width are within two millimetres of manual surgeon measurements.Timepoint: Day 0 after completion of both automated and manual measurements for each patient;Time required to complete wound assessment using the automated system from image capture to final measurements compared with time required for manual measurement by the surgeon.Timepoint: Day 0 during each imaging session for all enrolled patients;Performance of the automated segmentation and three dimensional reconstruction algorithm, assessed by investigator rating of wound boundary correctness and completeness on the reconstructed images.Timepoint: Day 0 to end of study at the time of image analysis;Usability and acceptability of the automated wound assessment system among surgeons and engineers measured using structured questionnaire scores.Timepoint: Day 0 immediately after device use during the same visit | — |
Countries
India
Contacts
Public ContactIng Vishwas Gowda P N
Mandya Institute of Medical Science
Outcome results
None listed