Multicenter Study Protocol: Research on Evaluation and Detec-tion of Surgical Wound Complications with AI-based Recogni-tion. (REDSCAR-trial)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 5
- 主要终点
- Efficacy of RedScar App
研究概览
简要总结
The increasing use of telemedicine in surgical care has demonstrated significant poten-tial for improving patient outcomes and optimizing healthcare resources. This study investigates the efficacy of the RedScar© app in telematic detection and monitoring of surgical site infections (SSIs), a major cause of healthcare-associated infections (HAIs) with significant economic and health impacts. RedScar© leverages a patient's smartphone to provide automated infection risk assessments without requiring clini-cian input, offering a potential solution for remote postoperative care. In a pilot study, RedScar© demonstrated 100% sensitivity and 83.13% specificity in detecting SSIs, with high patient satisfaction regarding its comfort, cost-effectiveness, and ability to reduce absenteeism. This multicenter prospective study aims to validate these findings, com-paring app-based detection with in-person evaluations. Primary objectives include as-sessing the sensitivity and specificity of RedScar© using receiver operating character-istic (ROC) analysis, while secondary objectives include evaluating patient satisfaction and standardizing telematic follow-up across centers. The study will include 168 pa-tients undergoing abdominal surgery, with follow-up assessments conducted remotely via the app and in-person at specified intervals. Data will be analysed using descrip-tive and statistical methods to assess diagnostic accuracy and patient satisfaction. This research seeks to further develop RedScar© as a reliable, scalable tool for enhancing postoperative care, reducing healthcare costs, and improving patient experiences in surgical recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
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
- •Participants must have signed an informed consent.
- •Participants must be over 18 years of age.
- •Participants must have undergone either urgent or scheduled surgery performed via laparotomy or laparoscopy.
- •Participants need access to a smartphone capable of downloading the app with android OS.
- •Either the participant or a close family member must be able to operate the app effectively.
- •Participants must be able to attend follow-up consultations at the surgical outpatient clinic after discharge, one week post-surgery, or earlier if the app flags a potential infection.
排除标准
- •Patients who lack access to a smartphone or are unable to properly use the app.
- •Patients unfamiliar with mobile devices or unable to comprehend the app's functionality or questions.
- •Patients who did not provide informed consent.
- •Patients who are unable to comply with the follow-up requirements.
结局指标
主要结局
Efficacy of RedScar App
时间窗: "From enrollment to the end of treatment at 8 weeks"
To assess the sensitivity and specificity of the RedScar© application for detecting wound infection, comparing the app with in-person diagnosis. The ROC curve will be used to analyze the overall performance of the app and identify the optimal cut-off for the "Red Proportion" (maximizing sensitivity and specificity).
次要结局
- Satisfaction Asessment(From enrollment to the end of treatment at 8 weeks)
研究者
Andrea Craus
Principal Investigator
Universitat de les Illes Balears
