Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475703
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-29
Brief Title:
Using AI Within Digital Wound Monitoring of Surgical Wounds to Prioritise Non-healing Wounds for Urgent Review
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Wound Imaging Software and Digital platfOrM to Detect and Prioritise Non-healing Surgical Wounds WISDOM
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WISDOM
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 firstredo 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
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 21 million having problems with wound healing of which 500000 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 firstredo 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 Bartholomews Hospital London and Freeman Hospital Newcastle Patients without a smartphonewith physical disabilitywith 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
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 firstredo 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 Bartholomews Hospital London and Freeman Hospital Newcastle Patients without a smartphonewith physical disabilitywith 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None