Using AI Within Digital Wound Monitoring of Surgical Wounds to Prioritise Non-healing Wounds for Urgent Review
NCT Number: NCT06475703
Acronym: WISDOM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgical Wound|Wound Healing Delayed|Heart; Surgery, Heart, Functional Disturbance as Result
Interventions: DEVICE: Isla wound prioritisation module|OTHER: Standard follow-up
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Collaborators: National Institute for Health Research, United Kingdom|University of Nottingham|Liverpool Heart and Chest Hospital NHS Foundation Trust|Islacare Ltd|Central and North West London NHS Foundation Trust|Derby Clinical Trials Unit|East Midlands Research Support Service|Centre for Healthcare Equipment and Technology Adoption|Health Innovation East Midlands
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-31
Completion Date: 2025-12-31
Locations: St Bartholomew's Hospital, London, EC1A 7BE, United Kingdom|Freeman Hospital, Newcastle Upon Tyne, NE7 7DN, United Kingdom

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)

Primary Outcome Measures: Quality of images assessed by clinicians, in frequencies, A quality image is one that can be used to make a clinical decision, 30 days|Quality of images assessed by clinicians, in percentages, A quality image is one that can be used to make a clinical decision, 30 days|Clinician satisfaction using surveys, Acceptability of the intervention including attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. Will also collect acceptability of being involved as a study participant. Survey variables that are continuous will be reported with means \& 95% confidence intervals (95% CI), if shown to be normally distributed, using a normality plot, otherwise will be reported with medians \& Interquartile Ranges (IQR). The categorical variables will be reported with frequencies \& percentages., 30 days|Clinician satisfaction using interviews, Acceptability of the intervention including attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. Will also collect acceptability of being involved as a study participant. Survey variables that are continuous will be reported with means \& 95% confidence intervals (95% CI), if shown to be normally distributed, using a normality plot, otherwise will be reported with medians \& Interquartile Ranges (IQR). The categorical variables will be reported with frequencies \& percentages., 30 days|Patient satisfaction using surveys, Acceptability of the intervention including attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. Will also collect acceptability of being involved as a study participant. Survey variables that are continuous will be reported with means \& 95% confidence intervals (95% CI), if shown to be normally distributed, using a normality plot, otherwise will be reported with medians \& Interquartile Ranges (IQR). The categorical variables will be reported with frequencies \& percentages., 30 days|Patient satisfaction using interviews, Acceptability of the intervention including attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs and self-efficacy. Will also collect acceptability of being involved as a study participant. Survey variables that are continuous will be reported with means \& 95% confidence intervals (95% CI), if shown to be normally distributed, using a normality plot, otherwise will be reported with medians \& Interquartile Ranges (IQR). The categorical variables will be reported with frequencies \& percentages., 30 days|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., Recruitment rate (including access and barriers to recruitment and willingness to be randomised) will be assessed as a percentage of all eligible patients, regardless of treatment allocation., 30 days|Adherence with the module (intervention group only). Adherence will be reported as the number and percentage of adherent patients in the intervention group., To be adherent a patient needs to submit 1 photo within the 30 day period., 30 days|Loss to follow-up (number and percentage of intervention patients complete the study), Loss to follow-up will be assessed based on all randomised patients., 30 days|Number of wound problems/infections (in number and percentage), Analysis will be reported based on allocated treatment., 30 days|Severity of wound problems/infections, Analysis will be reported based on allocated treatment., 30 days|Wound-related hospital admissions (in number and percentage), Analysis will be reported based on allocated treatment., 30 days|Prescribed antibiotics (in number and percentage), Analysis will be reported based on allocated treatment., 30 days|Time to review images in minutes (intervention only), Analysis will be reported based on allocated treatment., 30 days|Further surgery to treat wounds in number and percentage, Analysis will be reported based on allocated treatment., 30 days|Prescribed wound treatments, Analysis will be reported based on allocated treatment., 30 days|Number of clinic visits in number and percentage, Analysis will be reported based on allocated treatment., 30 days|Number of General Practice visits in frequency and percentage, Analysis will be reported based on allocated treatment., 30 days|Patient travel time in minutes, 30 days|Quality of life survey using SF-6D v2, At baseline, 30 days, and 60 days
Secondary Outcome Measures: Reasons for compliance/non-compliance will be explored in the staff surveys, Survey data will be analysed using descriptive statistics, and qualitative data from the interviews will be analysed using thematic analysis., 60 days|Reasons for compliance/non-compliance will be explored in the staff interviews, Survey data will be analysed using descriptive statistics, and qualitative data from the interviews will be analysed using thematic analysis., 60 days|Reasons for compliance/non-compliance will be explored in the patient intervention group surveys, Survey data will be analysed using descriptive statistics, and qualitative data from the interviews will be analysed using thematic analysis., 60 days|Reasons for compliance/non-compliance will be explored in the patient intervention group interviews, Survey data will be analysed using descriptive statistics, and qualitative data from the interviews will be analysed using thematic analysis., 60 days|Feasibility outcome: access/barriers to participation using survey, 60 days|Feasibility outcome: access/barriers to participation using interviews, 60 days|Feasibility outcome: willingness of participants to be randomised in number and percentage, 60 days|Feasibility outcome: attrition rate in percentage, 60 days|Feasibility outcome: time (in minutes) to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data, 60 days|Feasibility outcome: resources to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data, 60 days|Number of photos received per patient (number and percentage), 60 days|Number of wound images/non wound images (number and percentage), 60 days|Number of requests (for images) complied with - intervention group only (number and percentage), 60 days|Number photos initiated by patients - intervention group only (number and percentage), 60 days|Number of follow-up requests (number and percentage), 60 days