Using AI Within Digital Wound Monitoring of Surgical Wounds to Prioritise Non-healing Wounds for Urgent Review
WISDOM
Wound Imaging Software and Digital platfOrM to Detect and Prioritise Non-healing Surgical Wounds (WISDOM)
1 other identifier
interventional
120
1 country
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2024
CompletedFirst Posted
Study publicly available on registry
June 26, 2024
CompletedStudy Start
First participant enrolled
August 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2025
CompletedJune 12, 2025
June 1, 2025
7 months
April 29, 2024
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (20)
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 Outcomes (15)
Reasons for compliance/non-compliance will be explored in the staff surveys
60 days
Reasons for compliance/non-compliance will be explored in the staff interviews
60 days
Reasons for compliance/non-compliance will be explored in the patient intervention group surveys
60 days
Reasons for compliance/non-compliance will be explored in the patient intervention group interviews
60 days
Feasibility outcome: access/barriers to participation using survey
60 days
- +10 more secondary outcomes
Study Arms (2)
Isla digital wound monitoring + Standard follow-up
ACTIVE COMPARATORPatients in the intervention group will 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. The exception being the last request link which will remain open until 30 days after surgery. In the requests patients are asked to submit a photo of their wound and complete the UKHSA wound surveillance questionnaire. Participants can also submit an image during the 30 days whenever they have a concern.
Standard follow-up
ACTIVE COMPARATORPatients in the control group will have standard post-operative wound care follow-up for 60 days.
Interventions
The intervention group will use the artificial intelligence enabled platform with the new wound prioritisation module for 30 days after surgery in addition to standard post-operative wound follow-up care for 60 days after surgery.
Standard care, mapped during the economic scoping exercise may include; out-patient appointments, advised to contact GP, or no follow-up.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients having CABG requiring ventricular assist device (VAD) or
- extracorporeal membrane oxygenation (ECMO), or
- ventilated or unconscious patients, or
- pre-existing surgical site infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guy's and St Thomas' NHS Foundation Trustlead
- National Institute for Health Research, United Kingdomcollaborator
- University of Nottinghamcollaborator
- Liverpool Heart and Chest Hospital NHS Foundation Trustcollaborator
- Islacare Ltdcollaborator
- Central and North West London NHS Foundation Trustcollaborator
- Derby Clinical Trials Unitcollaborator
- East Midlands Research Support Servicecollaborator
- Centre for Healthcare Equipment and Technology Adoptioncollaborator
- Health Innovation East Midlandscollaborator
Study Sites (2)
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Publications (1)
Tanner J, Rochon M, Harris R, Beckhelling J, Jurkiewicz J, Mason L, Bouttell J, Bolton S, Dummer J, Wilson K, Dhoonmoon L, Cariaga K. Digital wound monitoring with artificial intelligence to prioritise surgical wounds in cardiac surgery patients for priority or standard review: protocol for a randomised feasibility trial (WISDOM). BMJ Open. 2024 Sep 17;14(9):e086486. doi: 10.1136/bmjopen-2024-086486.
PMID: 39289023DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Shipolini
Barts & The London NHS Trust
- PRINCIPAL INVESTIGATOR
Faruk Oezalp
Newcastle Hospitals NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2024
First Posted
June 26, 2024
Study Start
August 24, 2024
Primary Completion
March 23, 2025
Study Completion
March 23, 2025
Last Updated
June 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
On completion of the study, anonymised quantitative data from the surveys, interviews and phone calls and anonymised themed analysis of qualitative data from the interviews will be stored in and made publicly available through the University of Nottingham data repository (https://rdmc.nottingham.ac.uk/).