Surgical WoundWISDOMNCT06475703
Using AI Within Digital Wound Monitoring of Surgical Wounds to Prioritise Non-healing Wounds for Urgent Review
A study testing Isla wound prioritisation module and Standard follow-up in people with Surgical Wound and Wound Healing Delayed, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Wound Healing Delayed, Heart; Surgery, Heart, Functional Disturbance as Result
- What is being tested?
- Isla wound prioritisation module and Standard follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 24 Aug 2024to 23 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients having CABG requiring ventricular assist device (VAD) or
- extracorporeal membrane oxygenation (ECMO), or
- ventilated or unconscious patients, or
- pre-existing surgical site infection.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St Bartholomew's Hospital
London, EC1A 7BE
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
About this study
Official title: Wound Imaging Software and Digital platfOrM to Detect and Prioritise Non-healing Surgical Wounds (WISDOM)
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?
Read more
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)
Read the detailed description
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)
- Conditions
- Surgical Wound, Wound Healing Delayed, Heart; Surgery, Heart, Functional Disturbance as Result
- Being tested
- Isla wound prioritisation module, Standard follow-up
- Keywords
- artificial intelligence, wound management, surgery, surgical site infection, infection control
- Medical subject headings
- Surgical Wound, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isla wound prioritisation moduleDevice
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 follow-upOther
Standard care, mapped during the economic scoping exercise may include; out-patient appointments, advised to contact GP, or no follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Isla digital wound monitoring + Standard follow-up | Active comparator | Patients 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. Receives: Device: Isla wound prioritisation module; Other: Standard follow-up |
| Standard follow-up | Active comparator | Patients in the control group will have standard post-operative wound care follow-up for 60 days. Receives: Other: Standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of images assessed by clinicians, in frequencies
A quality image is one that can be used to make a clinical decision
Measured: 30 days
Quality of images assessed by clinicians, in percentages
A quality image is one that can be used to make a clinical decision
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Number of wound problems/infections (in number and percentage)
Analysis will be reported based on allocated treatment.
Measured: 30 days
Severity of wound problems/infections
Analysis will be reported based on allocated treatment.
Measured: 30 days
Wound-related hospital admissions (in number and percentage)
Analysis will be reported based on allocated treatment.
Measured: 30 days
Prescribed antibiotics (in number and percentage)
Analysis will be reported based on allocated treatment.
Measured: 30 days
Time to review images in minutes (intervention only)
Analysis will be reported based on allocated treatment.
Measured: 30 days
Further surgery to treat wounds in number and percentage
Analysis will be reported based on allocated treatment.
Measured: 30 days
Prescribed wound treatments
Analysis will be reported based on allocated treatment.
Measured: 30 days
Number of clinic visits in number and percentage
Analysis will be reported based on allocated treatment.
Measured: 30 days
Number of General Practice visits in frequency and percentage
Analysis will be reported based on allocated treatment.
Measured: 30 days
Patient travel time in minutes
Measured: 30 days
Quality of life survey using SF-6D v2
Measured: At baseline, 30 days, and 60 days
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 60 days
Feasibility outcome: access/barriers to participation using survey
Measured: 60 days
Feasibility outcome: access/barriers to participation using interviews
Measured: 60 days
Feasibility outcome: willingness of participants to be randomised in number and percentage
Measured: 60 days
Feasibility outcome: attrition rate in percentage
Measured: 60 days
Feasibility outcome: time (in minutes) to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data
Measured: 60 days
Feasibility outcome: resources to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data
Measured: 60 days
Number of photos received per patient (number and percentage)
Measured: 60 days
Number of wound images/non wound images (number and percentage)
Measured: 60 days
Number of requests (for images) complied with - intervention group only (number and percentage)
Measured: 60 days
Number photos initiated by patients - intervention group only (number and percentage)
Measured: 60 days
Number of follow-up requests (number and percentage)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start24 Aug 2024
- Primary completion23 Mar 2025
- Study completion23 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation: Mixed-block 1:1 randomisation stratified by site and sex managed by Derby CTSU. Intervention: The intervention group will use the AI enabled platform with the new AI module for 30 days after surgery in addition to standard post-operative wound follow-up care for 60 days after surgery. Participants will be asked to submit images and information every 7 days post operatively, up until 30 days. Participants can also submit an image during the 30 days whenever they have a concern. Control: The control group will receive standard post-operative wound follow-up care for 60 days after surgery.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Alex Shipolini, Principal investigator, Barts & The London NHS TrustFaruk Oezalp, Principal investigator, Newcastle Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475703
- Sponsor's protocol ID
- UHDB/2022/024
- Acronym
- WISDOM
- Status last verified
- Jun 2025
- First submitted
- 29 Apr 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/).
Publications
Tanner J, Rochon M, Cariaga K, Harris R, Beckhelling J, Bouttell J, Bolton S, Wilson K, Jurkiewicz J, Dhoonmoon L, Mostafa N, Dummer J, Basilio K, Magboo R, Procter K, McMillan C. Exploring patient and NHS staff acceptability of artificial intelligence-supported surgical wound monitoring within the WISDOM feasibility study: a multi-centre qualitative interview study. BMJ Open. 2026 Jul 31;16(7):e116323. doi: 10.1136/bmjopen-2026-116323.
PubMed 42538113Rochon M, Tanner J, Cariaga K, Jurkiewicz J, Beckhelling J, Harris R, Wilson K, Dhoonmoon L, Bolton S, Bouttell J, Davis D, Shipolini A, Magboo R, Oezalp F, Chester V. AI-enabled digital wound monitoring after cardiac surgery: a randomised controlled feasibility, safety, and acceptability trial. J Hosp Infect. 2026 Aug;174:428-435. doi: 10.1016/j.jhin.2026.04.020. Epub 2026 May 4.
PubMed 42092465Tanner 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.
PubMed 39289023
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Imaging Software and Digital platfOrM to Detect and Prioritise Non-healing Surgical Wounds (WISDOM)
- ClinicalTrials.gov ID
- NCT06475703
- Acronym / sponsor ID
- WISDOM / UHDB/2022/024
- Conditions
- Surgical Wound, Wound Healing Delayed, Heart; Surgery, Heart, Functional Disturbance as Result
- Keywords
- artificial intelligence, wound management, surgery, surgical site infection, infection control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- 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
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 23 Mar 2025 (actual)
- Study completion
- 23 Mar 2025 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomisation: Mixed-block 1:1 randomisation stratified by site and sex managed by Derby CTSU. Intervention: The intervention group will use the AI enabled platform with the new AI module for 30 days after surgery in addition to standard post-operative wound follow-up care for 60 days after surgery. Participants will be asked to submit images and information every 7 days post operatively, up until 30 days. Participants can also submit an image during the 30 days whenever they have a concern. Control: The control group will receive standard post-operative wound follow-up care for 60 days after surgery.
| Arm | Type | Receives |
|---|---|---|
| Isla digital wound monitoring + Standard follow-up | Active comparator | Device: Isla wound prioritisation module, Other: Standard follow-upPatients 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 comparator | Other: Standard follow-upPatients in the control group will have standard post-operative wound care follow-up for 60 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients having CABG requiring ventricular assist device (VAD) or
- extracorporeal membrane oxygenation (ECMO), or
- ventilated or unconscious patients, or
- pre-existing surgical site infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isla wound prioritisation moduleThe 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. | Device | Isla digital wound monitoring + Standard follow-up |
| Standard follow-upStandard care, mapped during the economic scoping exercise may include; out-patient appointments, advised to contact GP, or no follow-up. | Other | Isla digital wound monitoring + Standard follow-up, Standard follow-up |
Primary outcome
Quality of images assessed by clinicians, in frequencies
Time frame: 30 days
A quality image is one that can be used to make a clinical decision
Quality of images assessed by clinicians, in percentages
Time frame: 30 days
A quality image is one that can be used to make a clinical decision
Clinician satisfaction using surveys
Time frame: 30 days
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.
Clinician satisfaction using interviews
Time frame: 30 days
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.
Patient satisfaction using surveys
Time frame: 30 days
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.
Patient satisfaction using interviews
Time frame: 30 days
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.
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.
Time frame: 30 days
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.
Adherence with the module (intervention group only). Adherence will be reported as the number and percentage of adherent patients in the intervention group.
Time frame: 30 days
To be adherent a patient needs to submit 1 photo within the 30 day period.
Loss to follow-up (number and percentage of intervention patients complete the study)
Time frame: 30 days
Loss to follow-up will be assessed based on all randomised patients.
Number of wound problems/infections (in number and percentage)
Time frame: 30 days
Analysis will be reported based on allocated treatment.
Severity of wound problems/infections
Time frame: 30 days
Analysis will be reported based on allocated treatment.
Wound-related hospital admissions (in number and percentage)
Time frame: 30 days
Analysis will be reported based on allocated treatment.
Prescribed antibiotics (in number and percentage)
Time frame: 30 days
Analysis will be reported based on allocated treatment.
Time to review images in minutes (intervention only)
Time frame: 30 days
Analysis will be reported based on allocated treatment.
Further surgery to treat wounds in number and percentage
Time frame: 30 days
Analysis will be reported based on allocated treatment.
Prescribed wound treatments
Time frame: 30 days
Analysis will be reported based on allocated treatment.
Number of clinic visits in number and percentage
Time frame: 30 days
Analysis will be reported based on allocated treatment.
Number of General Practice visits in frequency and percentage
Time frame: 30 days
Analysis will be reported based on allocated treatment.
Patient travel time in minutes
Time frame: 30 days
Quality of life survey using SF-6D v2
Time frame: At baseline, 30 days, and 60 days
15 secondary outcomes
Reasons for compliance/non-compliance will be explored in the staff surveys
Time frame: 60 days
Reasons for compliance/non-compliance will be explored in the staff interviews
Time frame: 60 days
Reasons for compliance/non-compliance will be explored in the patient intervention group surveys
Time frame: 60 days
Reasons for compliance/non-compliance will be explored in the patient intervention group interviews
Time frame: 60 days
Feasibility outcome: access/barriers to participation using survey
Time frame: 60 days
Feasibility outcome: access/barriers to participation using interviews
Time frame: 60 days
Feasibility outcome: willingness of participants to be randomised in number and percentage
Time frame: 60 days
Feasibility outcome: attrition rate in percentage
Time frame: 60 days
Feasibility outcome: time (in minutes) to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data
Time frame: 60 days
Feasibility outcome: resources to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data
Time frame: 60 days
Number of photos received per patient (number and percentage)
Time frame: 60 days
Number of wound images/non wound images (number and percentage)
Time frame: 60 days
Number of requests (for images) complied with - intervention group only (number and percentage)
Time frame: 60 days
Number photos initiated by patients - intervention group only (number and percentage)
Time frame: 60 days
Number of follow-up requests (number and percentage)
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 42538113Tanner J, Rochon M, Cariaga K, Harris R, Beckhelling J, Bouttell J, Bolton S, Wilson K, Jurkiewicz J, Dhoonmoon L, Mostafa N, Dummer J, Basilio K, Magboo R, Procter K, McMillan C. Exploring patient and NHS staff acceptability of artificial intelligence-supported surgical wound monitoring within the WISDOM feasibility study: a multi-centre qualitative interview study. BMJ Open. 2026 Jul 31;16(7):e116323. doi: 10.1136/bmjopen-2026-116323.
- Derived from this study: PubMed 42092465Rochon M, Tanner J, Cariaga K, Jurkiewicz J, Beckhelling J, Harris R, Wilson K, Dhoonmoon L, Bolton S, Bouttell J, Davis D, Shipolini A, Magboo R, Oezalp F, Chester V. AI-enabled digital wound monitoring after cardiac surgery: a randomised controlled feasibility, safety, and acceptability trial. J Hosp Infect. 2026 Aug;174:428-435. doi: 10.1016/j.jhin.2026.04.020. Epub 2026 May 4.
- Derived from this study: PubMed 39289023Tanner 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.
- Individual participant dataSharing planned: Yes. 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/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Shipolini principal investigator
Barts & The London NHS Trust
Faruk Oezalp principal investigator
Newcastle Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isla wound prioritisation module and Standard follow-up in people with Surgical Wound and Wound Healing Delayed, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of images assessed by clinicians, in frequencies (time frame: 30 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06475703, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.