Research and Application Evaluation of Accurate Pressure Ulcer Area Measurement Technology Based on AI Grid Intelligent Recognition: A Self-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Pressure injury wound area
Study Overview
Brief Summary
The goal of this clinical trial is to learn if AI grid image recognition can measure pressure ulcer wound area accurately and efficiently in adult patients with pressure ulcers. The main questions it aims to answer are:
- Can AI grid image recognition shorten the single measurement time of pressure ulcer wound area?
- Is the wound area measured by AI grid image recognition consistent with the result from traditional manual grid counting? Researchers will compare AI grid image recognition measurement with traditional manual grid counting measurement on the same pressure ulcer wound image collected at a single time point to see if AI recognition achieves comparable accuracy with less operation time.
Participants will:
- Have standardized transparent grid dressing applied on their pressure ulcer wound
- Undergo one-time wound image collection
- Receive sequential wound area measurement using both methods on the captured single wound image
Detailed Description
This is a single-arm, self-controlled clinical trial enrolling adult inpatients with pressure ulcers. All enrolled subjects receive routine standardized wound care. A sterile transparent dressing printed with uniform standard grids will be applied onto the pressure ulcer wound surface for one-time image capture. Based on the single acquired wound image, two area measurement approaches will be performed sequentially: automated measurement via the AI grid image recognition system and manual measurement using the traditional grid counting method. The primary outcomes include single measurement operation time and the consistency of wound area results obtained from the two measurement techniques. All measurement data will be collected and statistically analyzed to verify whether AI grid recognition can achieve rapid and reliable area assessment of pressure ulcers in clinical settings.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
This study adopts an open-label design. All participants, care providers, investigators and outcome assessors are aware of the measurement method being used. Blinding is not feasible due to the obvious differences in the operation procedures and implementation modes between the AI grid image recognition measurement and the traditional manual grid counting measurement.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria:
- •Aged ≥18 years old;
- •Clinically diagnosed pressure injury of stage I-IV;
- •Patients or legal guardians sign informed consent;
- •Able to complete wound image acquisition.
Exclusion Criteria
- •Wounds with severe bleeding, active infection or extensive necrotic tissue unsuitable for film attachment;
- •Patients with severe skin allergic diseases who cannot tolerate transparent grid film;
- •Patients unable to cooperate with image collection;
- •Pregnant women;
- •Patients participating in other concurrent wound intervention trials.
- •Exclusion Criteria:
Arms & Interventions
Single Wound Measurement Group
All participants in this group receive standardized pressure ulcer wound measurement with a sterile transparent grid film at one single time point. After wound image capture, two measurement methods are carried out successively: AI grid intelligent recognition measurement and traditional manual grid counting measurement. The study compares the operation time and measurement consistency of the two evaluation methods on the same wound.
Intervention: AI Grid Image Recognition Measurement (Diagnostic Test)
Single Wound Measurement Group
All participants in this group receive standardized pressure ulcer wound measurement with a sterile transparent grid film at one single time point. After wound image capture, two measurement methods are carried out successively: AI grid intelligent recognition measurement and traditional manual grid counting measurement. The study compares the operation time and measurement consistency of the two evaluation methods on the same wound.
Intervention: Traditional Manual Grid Counting Measurement (Diagnostic Test)
Outcomes
Primary Outcomes
Pressure injury wound area
Time Frame: Baseline
To compare pressure injury area values obtained by AI automatic grid recognition measurement and manual grid counting gold standard.
Secondary Outcomes
- Wound measurement operation duration(Baseline)
Investigators
Honglei Wu
Associate Chief Nurse
Affiliated Hospital of Nantong University