Wound Imaging Software and Digital platfOrM to Detect and Prioritise Non-healing Surgical Wounds (WISDOM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Quality of images assessed by clinicians, in percentages
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients having CABG requiring ventricular assist device (VAD) or
- •extracorporeal membrane oxygenation (ECMO), or
- •ventilated or unconscious patients, or
- •pre-existing surgical site infection.
结局指标
主要结局
Quality of images assessed by clinicians, in percentages
时间窗: 30 days
A quality image is one that can be used to make a clinical decision
Clinician satisfaction using interviews
时间窗: 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
时间窗: 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.
Quality of images assessed by clinicians, in frequencies
时间窗: 30 days
A quality image is one that can be used to make a clinical decision
Clinician satisfaction using surveys
时间窗: 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
时间窗: 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.
时间窗: 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.
时间窗: 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)
时间窗: 30 days
Loss to follow-up will be assessed based on all randomised patients.
Number of wound problems/infections (in number and percentage)
时间窗: 30 days
Analysis will be reported based on allocated treatment.
Quality of life survey using SF-6D v2
时间窗: At baseline, 30 days, and 60 days
Severity of wound problems/infections
时间窗: 30 days
Analysis will be reported based on allocated treatment.
Wound-related hospital admissions (in number and percentage)
时间窗: 30 days
Analysis will be reported based on allocated treatment.
Prescribed antibiotics (in number and percentage)
时间窗: 30 days
Analysis will be reported based on allocated treatment.
Time to review images in minutes (intervention only)
时间窗: 30 days
Analysis will be reported based on allocated treatment.
Further surgery to treat wounds in number and percentage
时间窗: 30 days
Analysis will be reported based on allocated treatment.
Prescribed wound treatments
时间窗: 30 days
Analysis will be reported based on allocated treatment.
Number of clinic visits in number and percentage
时间窗: 30 days
Analysis will be reported based on allocated treatment.
Number of General Practice visits in frequency and percentage
时间窗: 30 days
Analysis will be reported based on allocated treatment.
Patient travel time in minutes
时间窗: 30 days
次要结局
- Feasibility outcome: attrition rate in percentage(60 days)
- Number of follow-up requests (number and percentage)(60 days)
- Feasibility outcome: access/barriers to participation using survey(60 days)
- Reasons for compliance/non-compliance will be explored in the staff interviews(60 days)
- Feasibility outcome: access/barriers to participation using interviews(60 days)
- Reasons for compliance/non-compliance will be explored in the staff surveys(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: willingness of participants to be randomised in number and percentage(60 days)
- Number of wound images/non wound images (number and percentage)(60 days)
- Feasibility outcome: time (in minutes) to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data(60 days)
- Feasibility outcome: resources to conduct telephone assessments to patients and phone calls to GPs to collect antibiotic data(60 days)
- Number photos initiated by patients - intervention group only (number and percentage)(60 days)
- Number of photos received per patient (number and percentage)(60 days)
- Number of requests (for images) complied with - intervention group only (number and percentage)(60 days)