Clinical trial NCT06475703: Using AI Within Digital Wound Monitoring of Surgical Wounds to Prioritise Non-healing Wounds for Urgent Review
Official title: Wound Imaging Software and Digital platfOrM to Detect and Prioritise Non-healing Surgical Wounds (WISDOM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Wound Healing Delayed
Heart; Surgery, Heart, Functional Disturbance as Result
Keywords: artificial intelligence
wound management
surgery
surgical site infection
infection control
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of Nottingham
name: Liverpool Heart and Chest Hospital NHS Foundation Trust
name: Islacare Ltd
name: Central and North West London NHS Foundation Trust
name: Derby Clinical Trials Unit
name: East Midlands Research Support Service
name: Centre for Healthcare Equipment and Technology Adoption
name: Health Innovation East Midlands
First posted: 2024-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomisation: Mixed-block 1:1 randomisation stratified by site and sex managed by Derby CTSU.

Intervention: The intervention group will use the AI enabled platform with the new AI module for 30 days after surgery in addition to standard post-operative wound follow-up care for 60 days after surgery. Participants will be asked to submit images and information every 7 days post operatively, up until 30 days. Participants can also submit an image during the 30 days whenever they have a concern.

Control: The control group will receive standard post-operative wound follow-up care for 60 days after surgery.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if artificial intelligence within digital wound monitoring of surgical wounds can prioritise non-healing wounds for urgent review in patients having first/redo CABG surgeries with or without additional cardiac procedures; could include any of the following: any gender, age ≥18. The main question it aims to answer is:

Can investigators successfully develop artificial intelligence to prioritise images of patients' surgical wounds that are failing to heal or are infected, in order to facilitate early treatment?

Researchers will compare the wound prioritisation module with standard care to determine safety and acceptability outcomes.

Participants from the control group will:

* Have standard post-operative wound care follow-up at day 30 (survey, interview and phone call)
* Have standard post-operative wound care follow-up at day 60 (phone call)

Participants from the intervention group will:

* Use platform with new AI prioritisation module for 30 days after surgery
* Be contacted via SMS text message seven days, fourteen days and twenty-one days after surgery with the link request remaining open for 6 days until the next request is sent out
* Submit a photo of their wound and complete the UKHSA wound surveillance questionnaire
* Have standard post-operative wound care follow-up at day 30 (survey, interview and phone call)
* Have standard post-operative wound care follow-up at day 60 (phone call)

Detailed description: Background and study aims Over 10 million surgical operations are performed in England annually with approximately 2.1 million having problems with wound healing, of which 500,000 lead to infection. Most of these wound problems happen after patients have been discharged from the hospital. They need to be identified and treated early to prevent the problem from worsening.

Digital remote surgical wound monitoring is beginning to be used to monitor patients' surgical wounds at home after discharge from the hospital. This offers regular assessment when wound problems are most likely to develop. Early evaluations of digital wound monitoring suggest it improves clinical outcomes and has high patient satisfaction; however, it creates a new additional workload for clinicians.

Who can participate? Patients ≥18 years old having first/redo coronary artery bypass graft (CABG) surgeries with or without adjunct cardiac procedures such as valve replacement, or chest reopening during same admission as index surgery, and either no infection, or an existing non-infected wound complication, or any other infection except surgical site, at any of two recruitment sites (St Bartholomew's Hospital, London and Freeman Hospital, Newcastle). Patients without a smartphone/with physical disability/with visual impairment will be eligible if they are willing to use a smartphone or internet provided by the study, or their next of kin or carer is able-bodied or has a smartphone.

What does the study involve? The study will assess a new component for a digital wound monitoring platform, which has been developed and has recently received HRA approval to be validated for predictivity, sensitivity and specificity, and inter-rater reliability. The new component uses artificial intelligence (AI) to identify 'red flags' on the images patients submit to the wound monitoring platform. Images that have a possible red flag are then identified for urgent priority review. This helps clinicians manage this new workload by allowing the most urgent cases to be reviewed first.

A total of 120 patients in two hospitals will be invited to take part in the study. All participants (patients who take part) will receive normal wound care follow-up after surgery, and half of the participants will also receive the digital wound monitoring system with the AI to identify wounds which need urgent assessment.

What are the possible benefits and risks of participating? Participants allocated to the digital wound monitoring with AI may benefit from regular and ongoing wound assessment. Participants allocated to standard wound care may not receive additional direct benefits. This study will help improve the approach to Wound care.

There are no foreseeable disadvantages involved with taking part since all participants will receive their usual standard wound care follow-up. Being involved will require participants to give some of their own time.

Where is the study run from? This study is a collaboration of researchers and surgeons across the country. It is co-ordinated by Derby Clinical Trials Support Unit, on behalf of the Sponsor, Guys and St Thomas' NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for? December 2023 to December 2025

Who is funding the study? National Institute for Health and Care Research (NIHR) (UK)

Eligibility criteria: Inclusion Criteria:

* Patients having first/redo CABG surgeries with or without adjunct cardiac procedures such as valve replacement, or chest reopening during same admission as index surgery, and either no infection, or an existing non-infected wound complication, or any other infection except surgical site.
* Patients without a smartphone/with physical disability/with visual impairment will be eligible if they are willing to use a smartphone or internet provided by the study, or their next of kin or carer is able-bodied or has a smartphone.

Exclusion Criteria:

* Patients having CABG requiring ventricular assist device (VAD) or
* extracorporeal membrane oxygenation (ECMO), or
* ventilated or unconscious patients, or
* pre-existing surgical site infection.

Primary outcomes:
measure: Quality of images assessed by clinicians, in frequencies
timeFrame: 30 days
measure: Quality of images assessed by clinicians, in percentages
timeFrame: 30 days
measure: Clinician satisfaction using surveys
timeFrame: 30 days
measure: Clinician satisfaction using interviews
timeFrame: 30 days
measure: Patient satisfaction using surveys
timeFrame: 30 days
measure: Patient satisfaction using interviews
timeFrame: 30 days
measure: Recruitment rate (number and percentage of eligible patients recruited to the study). Patients who were consented but not randomised will not be included in the recruitment rate.
timeFrame: 30 days
measure: Adherence with the module (intervention group only). Adherence will be reported as the number and percentage of adherent patients in the intervention group.
timeFrame: 30 days
measure: Loss to follow-up (number and percentage of intervention patients complete the study)
timeFrame: 30 days
measure: Number of wound problems/infections (in number and percentage)
timeFrame: 30 days
measure: Severity of wound problems/infections
timeFrame: 30 days
measure: Wound-related hospital admissions (in number and percentage)
timeFrame: 30 days
measure: Prescribed antibiotics (in number and percentage)
timeFrame: 30 days
measure: Time to review images in minutes (intervention only)
timeFrame: 30 days
measure: Further surgery to treat wounds in number and percentage
timeFrame: 30 days
measure: Prescribed wound treatments
timeFrame: 30 days
measure: Number of clinic visits in number and percentage
timeFrame: 30 days
measure: Number of General Practice visits in frequency and percentage
timeFrame: 30 days
measure: Patient travel time in minutes
timeFrame: 30 days
measure: Quality of life survey using SF-6D v2
timeFrame: At baseline, 30 days, and 60 days
Secondary outcomes:
measure: Reasons for compliance/non-compliance will be explored in the staff surveys
timeFrame: 60 days
measure: Reasons for compliance/non-compliance will be explored in the staff interviews
timeFrame: 60 days
measure: Reasons for compliance/non-compliance will be explored in the patient intervention group surveys
timeFrame: 60 days
measure: Reasons for compliance/non-compliance will be explored in the patient intervention group interviews
timeFrame: 60 days
measure: Feasibility outcome: access/barriers to participation using survey
timeFrame: 60 days
measure: Feasibility outcome: access/barriers to participation using interviews
timeFrame: 60 days
measure: Feasibility outcome: willingness of participants to be randomised in number and percentage
timeFrame: 60 days
measure: Feasibility outcome: attrition rate in percentage
timeFrame: 60 days
measure: Feasibility outcome: time (in minutes) to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data
timeFrame: 60 days
measure: Feasibility outcome: resources to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data
timeFrame: 60 days
measure: Number of photos received per patient (number and percentage)
timeFrame: 60 days
measure: Number of wound images/non wound images (number and percentage)
timeFrame: 60 days
measure: Number of requests (for images) complied with - intervention group only (number and percentage)
timeFrame: 60 days
measure: Number photos initiated by patients - intervention group only (number and percentage)
timeFrame: 60 days
measure: Number of follow-up requests (number and percentage)
timeFrame: 60 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Bartholomew&#39;s Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Barts & The London NHS Trust
name: Alex Shipolini
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle Hospitals NHS Foundation Trust
name: Faruk Oezalp
role: PRINCIPAL_INVESTIGATOR
References: