Surgical Wound InfectionPhase 2/3REDSCARNCT06771726
Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)
A Phase 2/3 study testing RedScar App in people with Surgical Wound Infection, run by Universitat de les Illes Balears at 5 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- RedScar App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 5 sitesSpain
- Study dates
- 1 Jan 2024to Dec 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 2 recruiting
- Completed
Hospital de Fuenlabrada
Madrid
- Recruiting
Hospital Universitario Severo Ochoa
Madrid
Mikel Rojo, 0034 914 81 80 00, mrojoabecia@gmail.com
- Recruiting
Hospital General Mateu Orfila
Mahón
Fernando Alcaide Matas, 0034 971 48 70 00, fernando.alcaide@hgmo.es
- Completed
Hospital Universitario Son Espases
Palma
- Completed
Universidad Islas Baleares
Palma
About this study
Official title: Multicenter Study Protocol: Research on Evaluation and Detec-tion of Surgical Wound Complications with AI-based Recogni-tion. (REDSCAR-trial)
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.
- Conditions
- Surgical Wound Infection
- Being tested
- RedScar App
- Keywords
- surgical wound infection, Telemedicine, smartphone application, artificial intelligence
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RedScar AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Redscar app | Experimental | Telematic follow-up with App Receives: Device: RedScar App |
| In-Person | No intervention | In-person visit to the clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: "From enrollment to the end of treatment at 8 weeks"
Secondary outcomes (1)
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.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de les Illes Balears
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Craus, Universitat de les Illes Balears
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771726
- Sponsor's protocol ID
- IB 5087/22 PI
- Other IDs
- PID2020-113870GB-I00
- Acronym
- REDSCAR
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 39768786Segura-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.
PubMed 28794868
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study Protocol: Research on Evaluation and Detec-tion of Surgical Wound Complications with AI-based Recogni-tion. (REDSCAR-trial)
- ClinicalTrials.gov ID
- NCT06771726
- Acronym / sponsor ID
- REDSCAR / IB 5087/22 PI
- Conditions
- Surgical Wound Infection
- Keywords
- surgical wound infection, Telemedicine, smartphone application, artificial intelligence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Universitat de les Illes BalearsUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Jan 2025 (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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Redscar app | Experimental | Device: RedScar AppTelematic follow-up with App |
| In-Person | No intervention | –In-person visit to the clinics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| RedScar Appuse 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. | Device | Redscar app |
Primary outcome
Efficacy of RedScar App
Time frame: "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).
1 secondary outcome
Satisfaction Asessment
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Background: PubMed 39768786Craus-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.
- Background: PubMed 28794868Segura-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.
- RedScar Image RepositoryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
Related trials for Surgical Wound Infection
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
RecruitingPhase 1
A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess
Surgical Wound Infection, Traumatic Wound Infection
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RedScar App in people with Surgical Wound Infection, run by Universitat de les Illes Balears at 5 sites in Spain.
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 6 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: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Craus-Miguel, MD, cPhD (0034 661115968, acrausm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of RedScar App (time frame: "From enrollment to the end of treatment at 8 weeks"). 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 NCT06771726, which also lists 2 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 20 Jan 2025.