Wound Imaging Software and Digital platfOrM to Detect and Prioritise Non-healing Surgical Wounds (WISDOM)
Trial ID: NCT06475703
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-08-24
Completion date: 2025-03-23
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
Conditions: Surgical Wound; Wound Healing Delayed; Heart; Surgery, Heart, Functional Disturbance as Result
Interventions: Isla wound prioritisation module; Standard follow-up
Locations: St Bartholomew&#39;s Hospital; Freeman Hospital
Countries: United Kingdom; United Kingdom
Enrollment: 120
Age range: 18 Years - None
Sex: ALL

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)

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.

Outcomes:
Quality of images assessed by clinicians, in frequencies; Quality of images assessed by clinicians, in percentages; Clinician satisfaction using surveys; Clinician satisfaction using interviews; Patient satisfaction using surveys; Patient satisfaction using interviews; 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.; Adherence with the module (intervention group only). Adherence will be reported as the number and percentage of adherent patients in the intervention group.; Loss to follow-up (number and percentage of intervention patients complete the study); Number of wound problems/infections (in number and percentage); Severity of wound problems/infections; Wound-related hospital admissions (in number and percentage); Prescribed antibiotics (in number and percentage); Time to review images in minutes (intervention only); Further surgery to treat wounds in number and percentage; Prescribed wound treatments; Number of clinic visits in number and percentage; Number of General Practice visits in frequency and percentage; Patient travel time in minutes; Quality of life survey using SF-6D v2