Surgical Site InfectionAI/SSINCT07438314
Artificial Intelligence-Based Educational Guide
A study testing Artificial Intelligence-Based educational guide in people with Surgical Site Infection, run by Mansoura University at 1 site in Egypt.
Trial summary
The study aimed to evaluate the effectiveness of an artificial intelligence-based educational guide to prevent surgical site infection among women delivering via cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Artificial Intelligence-Based educational guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Feb 2025to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 20-60 years who delivered via cesarean section (CS).
- Own a smartphone with internet access.
- Have basic digital literacy, defined as the ability to use mobile applications, read text messages, and communicate via WhatsApp or similar platforms.
- Agree to participate voluntarily and provide informed consent.
Who cannot join
- Women with severe comorbid medical or psychiatric conditions that may affect their participation or comprehension.
- Women without smartphone access or with limited digital skills that prevent them from interacting with the AI-based educational guide.
- Women with communication difficulties (e.g., hearing or speech impairment) that hinder engagement with the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Artificial Intelligence-Based Educational Guide to Prevent Surgical Site Infection Among Women Delivering Via Caesarean Section
The study aimed to evaluate the effectiveness of an artificial intelligence-based educational guide to prevent surgical site infection among women delivering via cesarean section.
Research hypotheses:
Read more
H0: An artificial intelligence-based educational guide will not have any effect on reducing the rate of surgical site infection among women delivering via caesarean section.
H1: An artificial intelligence-based educational guide will have a significant positive effect on reducing the rate of surgical site infection among women delivering via cesarean section.
A purposive sample of 300 CS delivered women was divided randomly by using computer-generated randomization. into a control and intervention group, 150 women each. The control group received standard care. The intervention group received standard care plus the Artificial Intelligence guide
- After discharge, the researcher contacts study subjects every day by WhatsApp and phone call for any questions and to remind them of the upcoming follow-up visit.
- Women were asked to photograph the incision site and send it via WhatsApp using an end-to-end encrypted messaging platform to evaluate the wound condition. All photos were deleted immediately after completing the study for women's privacy.
- At the 10th postoperative day (±3 days), a follow-up was performed in the Outpatient Clinic because the majority of SSIs developed between POD5 and POD10, and due to the importance of timely identification and referral of SSIs.
- According to the study protocol, all women were followed until 30 days after CS. Follow-up was performed in the outpatient clinic, and post-CS SSI screening questions were asked, a physical examination of the patient and determined whether the patient had an SSI as per the Centers for Disease Control and Prevention definition.
Read the detailed description
Surgical site infections (SSIs) remain a significant concern in obstetric care, particularly following cesarean sections (CS), which are among the most frequently performed surgical procedures worldwide. SSIs not only prolong hospital stays but also increase healthcare costs and contribute to maternal morbidity. Emerging technologies, particularly artificial intelligence (AI), offer promising avenues for enhancing patient education and infection prevention strategies. Recent research demonstrated the potential of AI in healthcare education and infection control. A recent study found that AI-based educational programs significantly improved patients' knowledge and adherence to infection prevention protocols, leading to a 50% reduction in SSI rates post-cesarean section.
Many women, particularly those in rural or underserved communities, have limited access to healthcare professionals and postoperative follow-up care. AI-based educational tools, which can be delivered via mobile applications, SMS alerts, or digital platforms, have the potential to overcome geographical and economic barriers. This study supports the scalability and accessibility of AI-driven health education, particularly for vulnerable populations who may otherwise lack essential postoperative guidance
- Conditions
- Surgical Site Infection
- Being tested
- Artificial Intelligence-Based educational guide
- 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.
Artificial Intelligence-Based educational guideOther
The artifactual intelligence-based educational guide regarding cesarean section wound care provided for women after delivery and followed through with Daily educational messages, interactive dialogue, Reminders and alerts, Automated symptom checklists, and Photo-based wound monitoring
| Study group | Role | What they receive |
|---|---|---|
| AI intervention | Experimental | * After discharge, the researcher contacts study subjects every day by WhatsApp and phone call for any questions and to remind them of the upcoming follow-up visit.
* Women were asked to photograph the incision site and send it via WhatsApp using an end-to-end encrypted messaging platform to evaluate the wound condition. All photos were deleted immediately after completing the study for women's privacy.
* At the postoperative day (±3 days), follow-up was performed in the Outpatient Clinic because the majority of SSIs developed between POD5 and POD10, and due to the importance of timely identification and referral of SSIs (Sway et al., 2019).
* According to the study protocol all women were followed until 30 days after CS. Follow-up was performed in the Outpatient Clinic and post-CS SSI screening questions were asked. a physical examination of the patient was determined whether the patient had an SSI as per the Centers for Disease Control and Prevention definition Gave all instruction Receives: Other: Artificial Intelligence-Based educational guide |
| ordinary intervention | Active comparator | women receive the usual nursing care Receives: Other: Artificial Intelligence-Based educational guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
A structured interview Questionnaire
This questionnaire consists of two parts:
Part one is to obtain information about cesarean section women's demographic and obstetric characteristics (Age, Residence, Obstetric characteristics, Parity, Gestational age, Labor before operation, Status of membrane) and phone number Part two: to obtain information about medical history (pre-existing conditions, diabetes mellitus, anemia, obesity, hypertension).
Part three: to obtain information about cesarean section women's Operational characteristics (Type of the CS, Duration of CS, pre and postoperative antibiotic prophylaxis, Type of Abdominal incision, Post-operative hospital stay, Type of Anesthesia, intraoperative complications, Bleeding (> 1000 ml), blood transfusion, duration of operation, days in hospital postoperatively, patients' medication list and from the discharge list
Measured: 30 days after CS
Secondary outcomes (1)
Criteria for defining surgical site infection (SSI). From US Centers for Disease Control and Prevention (CDC definition)(CDC, 2007).
This tool included criteria for defining surgical site infection (SSI) by CDC including:
Superficial incisional SSI, Infection occurred within 30 days after the operation and the infec involves only skin or subcutaneous tissue of the incision and at least one of the following:
- Purulent drainage
- Organisms isolated from an aseptically obtained culture
- At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat, and the superficial incision is deliberately opened by surgeon, unless incision is culture-negative
- Diagnosis of superficial incisional surgical site infection (SSI) by the surgeon or attending physician.
Deep incisional SSI: Infection occurred 30 days after the operation, and the infection involved deep soft tissue of the incision and at least one of the following:
- Purulent drainage from the deep incision
- A deep incision spontaneously dehisces or is deliberately opened.
Measured: 30 days after CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start17 Feb 2025
- Primary completion10 Oct 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madiha hassan nabih mohamed, Mansoura University
- Investigators
- Madiha HN Mohamed, professor, Principal investigator, faculty of nursing Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438314
- Sponsor's protocol ID
- 0657
- Acronym
- AI/SSI
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Artificial Intelligence-Based Educational Guide to Prevent Surgical Site Infection Among Women Delivering Via Caesarean Section
- ClinicalTrials.gov ID
- NCT07438314
- Acronym / sponsor ID
- AI/SSI / 0657
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 27 Feb 2026 (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 study aimed to evaluate the effectiveness of an artificial intelligence-based educational guide to prevent surgical site infection among women delivering via cesarean section.
Research hypotheses:
H0: An artificial intelligence-based educational guide will not have any effect on reducing the rate of surgical site infection among women delivering via caesarean section.
H1: An artificial intelligence-based educational guide will have a significant positive effect on reducing the rate of surgical site infection among women delivering via cesarean section.
A purposive sample of 300 CS delivered women was divided randomly by using computer-generated randomization. into a control and intervention group, 150 women each. The control group received standard care. The intervention group received standard care plus the Artificial Intelligence guide
- After discharge, the researcher contacts study subjects every day by WhatsApp and phone call for any questions and to remind them of the upcoming follow-up visit.
- Women were asked to photograph the incision site and send it via WhatsApp using an end-to-end encrypted messaging platform to evaluate the wound condition. All photos were deleted immediately after completing the study for women's privacy.
- At the 10th postoperative day (±3 days), a follow-up was performed in the Outpatient Clinic because the majority of SSIs developed between POD5 and POD10, and due to the importance of timely identification and referral of SSIs.
- According to the study protocol, all women were followed until 30 days after CS. Follow-up was performed in the outpatient clinic, and post-CS SSI screening questions were asked, a physical examination of the patient and determined whether the patient had an SSI as per the Centers for Disease Control and Prevention definition.
Detailed description
Surgical site infections (SSIs) remain a significant concern in obstetric care, particularly following cesarean sections (CS), which are among the most frequently performed surgical procedures worldwide. SSIs not only prolong hospital stays but also increase healthcare costs and contribute to maternal morbidity. Emerging technologies, particularly artificial intelligence (AI), offer promising avenues for enhancing patient education and infection prevention strategies. Recent research demonstrated the potential of AI in healthcare education and infection control. A recent study found that AI-based educational programs significantly improved patients' knowledge and adherence to infection prevention protocols, leading to a 50% reduction in SSI rates post-cesarean section.
Many women, particularly those in rural or underserved communities, have limited access to healthcare professionals and postoperative follow-up care. AI-based educational tools, which can be delivered via mobile applications, SMS alerts, or digital platforms, have the potential to overcome geographical and economic barriers. This study supports the scalability and accessibility of AI-driven health education, particularly for vulnerable populations who may otherwise lack essential postoperative guidance
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI intervention | Experimental | Other: Artificial Intelligence-Based educational guide* After discharge, the researcher contacts study subjects every day by WhatsApp and phone call for any questions and to remind them of the upcoming follow-up visit. * Women were asked to photograph the incision site and send it via WhatsApp using an end-to-end encrypted messaging platform to evaluate the wound condition. All photos were deleted immediately after completing the study for women's privacy. * At the postoperative day (±3 days), follow-up was performed in the Outpatient Clinic because the majority of SSIs developed between POD5 and POD10, and due to the importance of timely identification and referral of SSIs (Sway et al., 2019). * According to the study protocol all women were followed until 30 days after CS. Follow-up was performed in the Outpatient Clinic and post-CS SSI screening questions were asked. a physical examination of the patient was determined whether the patient had an SSI as per the Centers for Disease Control and Prevention definition Gave all instruction |
| ordinary intervention | Active comparator | Other: Artificial Intelligence-Based educational guidewomen receive the usual nursing care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 20-60 years who delivered via cesarean section (CS).
- Own a smartphone with internet access.
- Have basic digital literacy, defined as the ability to use mobile applications, read text messages, and communicate via WhatsApp or similar platforms.
- Agree to participate voluntarily and provide informed consent.
Key exclusion criteria (3 listed)
- Women with severe comorbid medical or psychiatric conditions that may affect their participation or comprehension.
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 |
|---|---|---|
| Artificial Intelligence-Based educational guideThe artifactual intelligence-based educational guide regarding cesarean section wound care provided for women after delivery and followed through with Daily educational messages, interactive dialogue, Reminders and alerts, Automated symptom checklists, and Photo-based wound monitoring | Other | AI intervention, ordinary intervention |
Primary outcome
A structured interview Questionnaire
Time frame: 30 days after CS
This questionnaire consists of two parts: Part one is to obtain information about cesarean section women's demographic and obstetric characteristics (Age, Residence, Obstetric characteristics, Parity, Gestational age, Labor before operation, Status of membrane) and phone number Part two: to obtain information about medical history (pre-existing conditions, diabetes mellitus, anemia, obesity, hypertension). Part three: to obtain information about cesarean section women's Operational characteristics (Type of the CS, Duration of CS, pre and postoperative antibiotic prophylaxis, Type of Abdominal incision, Post-operative hospital stay, Type of Anesthesia, intraoperative complications, Bleeding (> 1000 ml), blood transfusion, duration of operation, days in hospital postoperatively, patients' medication list and from the discharge list
1 secondary outcome
Criteria for defining surgical site infection (SSI). From US Centers for Disease Control and Prevention (CDC definition)(CDC, 2007).
Time frame: 30 days after CS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Madiha HN Mohamed, professor principal investigator
faculty of nursing Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-Based educational guide in people with Surgical Site Infection, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A structured interview Questionnaire (time frame: 30 days after CS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.