跳至主要内容
临床试验/NCT06771726
NCT06771726招募中2 期

Multicenter Study Protocol: Research on Evaluation and Detec-tion of Surgical Wound Complications with AI-based Recogni-tion. (REDSCAR-trial)

Universitat de les Illes Balears5 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2024年1月1日最近更新:
适应症

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

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

发起方
Universitat de les Illes Balears
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Craus

Principal Investigator

Universitat de les Illes Balears

研究点 (5)

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