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)
