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| ID | Type | Description | Link |
|---|---|---|---|
| PID2020-113870GB-I00 | Other Grant/Funding Number | MCIN/AEI/10.13039/501100011033 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Redscar app | Experimental | Telematic follow-up with App |
|
| In-Person | No Intervention | In-person visit to the clinics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RedScar App | Device | use of the RedScar© app on patients' smartphones. Patients will complete a brief health questionnaire and upload a wound photograph to the app, which will provide recommendations based on the risk of infection detected. Simultaneously, an in-person wound assessment will be conducted by the investigator to compare results. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of RedScar App | 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). | "From enrollment to the end of treatment at 8 weeks" |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Asessment | Assess the satisfaction level of subjects undergoing telemedicine-based follow-up using a validated telemedicine satisfaction questionnaire (Yip et al.). Minimum: 0. Maximum: 14. Higher scores mean a better satisfaction. | From enrollment to the end of treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Craus-Miguel, MD, cPhD | Contact | 0034 661115968 | acrausm@gmail.com | |
| Juan José Segura-Sampedro, MD, PhD | Contact | 0034 637028024 | juanjose.segura@salud.madrid.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Fuenlabrada | Completed | Madrid | Spain | |||
| Hospital Universitario Severo Ochoa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39768786 | Background | Craus-Miguel A, Munar M, Moya-Alcover G, Contreras-Nogales AM, Gonzalez-Hidalgo M, Segura-Sampedro JJ. Enhancing Surgical Wound Monitoring: A Paired Cohort Study Evaluating a New AI-Based Application for Automatic Detection of Potential Infections. J Clin Med. 2024 Dec 23;13(24):7863. doi: 10.3390/jcm13247863. | |
| 28794868 | Background |
| Label | URL |
|---|---|
| RedScar Image Repository | View source |
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A virtual repository of surgical wound photographs was created and made available to other researchers. This repository can be accessed through the website redscar.uib.es
2023-No limit
Authorization must be granted via email.
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This multicenter prospective study uses a paired cohort design with a non-randomized, single-blinded approach, where each participant served as their own control. The investigators remain unaware of the application's recommendations dur-ing wound assessments. The study will include adult patients undergoing abdominal surgery at different hospitals. This study involves the use of the RedScar© app on pa-tients' smartphones. Patients will complete a brief health questionnaire and upload a wound photograph to the app, which will provide recommendations based on the risk of infection detected. Simultaneously, an in-person wound assessment will be con-ducted by the investigator to compare results.
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|
| Recruiting |
| Madrid |
| Spain |
|
| Hospital General Mateu Orfila | Recruiting | Mahón | Spain |
|
| Hospital Universitario Son Espases | Completed | Palma | Spain |
| Universidad Islas Baleares | Completed | Palma | Spain |
| Segura-Sampedro JJ, Rivero-Belenchon I, Pino-Diaz V, Rodriguez Sanchez MC, Pareja-Ciuro F, Padillo-Ruiz J, Jimenez-Rodriguez RM. Feasibility and safety of surgical wound remote follow-up by smart phone in appendectomy: A pilot study. Ann Med Surg (Lond). 2017 Jul 18;21:58-62. doi: 10.1016/j.amsu.2017.07.040. eCollection 2017 Sep. |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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