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Surgical InfectionNCT07205939

Evaluation of Surgical Site Infection After Cesarean Section

A study testing Mobile Application usage in people with Surgical Infection and Cesarean Section Wound, run by Sibel Bulut Haklı at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate surgical site monitoring after cesarean section using a mobile application currently being developed. This mobile application aims to facilitate early diagnosis of surgical site infection, reduce clinic visits for wound monitoring, and consequently reduce labor, travel, and care costs. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Surgical Infection, Cesarean Section Wound
What is being tested?
Mobile Application usage
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Jan 2025to 5 Feb 2026
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 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women who have had a Caesarean section
  • Aged between 18 and 45 years
  • Own a smartphone with internet access
  • Provide informed consent
  • Have adequate Turkish reading comprehension

Who cannot join

  • Presence of illnesses that prevent the use of the online survey or application (e.g., visual impairment, neuropsychiatric illness)
  • Failure to comply with study procedures (e.g., incomplete or missing forms)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istinye University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Remote Assessment of the Permanent Site After Cesarean Section: A Randomized Controlled Trial

This study aims to investigate surgical site monitoring after cesarean section using a mobile application currently being developed. This mobile application aims to facilitate early diagnosis of surgical site infection, reduce clinic visits for wound monitoring, and consequently reduce labor, travel, and care costs. In this context, a randomized controlled design will be conducted between the study and control groups to compare surgical site infection rates, time to diagnosis, number of clinic visits, frequency of hospitalization, care costs, and patient satisfaction.

Read the detailed description

While birth occurs spontaneously and naturally at the end of pregnancy due to a woman's normal physiology, intervention is required if a condition endangers the pregnant woman or the fetus. Cesarean section is the surgical procedure of choice when vaginal birth threatens maternal or fetal health, or when vaginal birth is not possible for various reasons. Cesarean section rates (both emergency and elective) range from 5% to 20%, and rates continue to increase in all countries. The frequency of Cesarean sections has increased by 75% over the last 15 years. The term surgical site infection (SSI) was coined by the Surgical Wound Infection Task Force in 1992. In its broader sense, SSI is classified as an infection that occurs within 30 days after surgery, either due to an incision or deep tissue injury. Bacteria entering through the incision line during surgery are the cause of the spread of potentially life-threatening surgical site viruses each year and contribute to the rise in antibiotic resistance. In low- and middle-income families, 11% of patients undergoing surgery develop this condition during this time.

More than 2 million laparotomies are performed annually for benign conditions in the United States. More than half of these (1 million cesarean sections and 500,000 hysterectomies) are obstetric and gynecological procedures. Although precise figures for similar data are not available in Turkey, it is known that the frequency of cesarean sections is quite high. Among all OECD (Organization for Economic Cooperation and Development) countries, Turkey has the second-highest cesarean section rate at 57.3%. The estimated incidence of SSI ranges from 3% to 15% for cesarean sections and 3% to 8% for abdominal hysterectomies. 3% to 14% of cesarean sections are complicated by wound seroma and hematoma. In Africa, up to 20% of cesarean section patients develop a wound infection, compromising their health and their ability to care for their babies. Post-cesarean SSI can be associated with many factors. These include age, body mass index (BMI), inadequate antenatal care, smoking, diabetes mellitus, hypertensive disorders, and multiple pregnancies, as well as intrapartum risk factors such as emergency cesarean section, prolonged labor, premature rupture of membranes, frequent vaginal examinations, and chorioamnionitis. Western sources estimate hospital expenses per wound. Therefore, the direct costs of laparotomy wounds in obstetrics and gynecology can reach $180 to $500 million annually. These figures do not include home wound care and nursing, dressings, additional office visits, lost work, and physical and psychosocial costs for the patient. In the short term, wound dehiscence prolongs postoperative pain and healing time, while also contributing to protein and nitrogen loss. In the long term, a severed, infected wound can lead to scarring and an increased risk of herniation. The emotional and social consequences are less well known, and the impact on the development of chronic pain is unknown. Telehealth is the sharing of health data, care information, and education between healthcare personnel and patients, students, and other healthcare professionals via telecommunications, using telephones, computers, interactive television, or a combination of these. The COVID-19 pandemic, in particular, has highlighted the need for the creation and expansion of telehealth systems. Telehealth systems aim to identify changes in patients' vital signs early, provide early intervention, reduce the number of home visits, reduce the number of emergency room and outpatient clinic visits, reduce hospitalization rates, hospitalization duration, and care costs, while also improving patient self-care. This study aimed to investigate surgical site control after cesarean section using a mobile application being developed.

Being tested
Mobile Application usage
Keywords
mobile application, cesarean section, surgical site infection
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.

  • Mobile Application usageDevice

    Also called SurgiMomma

    Articipants complete a brief symptom questionnaire and upload a standardized photo of the cesarean incision on postpartum days 3, 7, and 15 (±1 day) via the study mobile platform. Patients will be reminded remotely on these mandatory days. They will be informed that if they have concerns about the wound outside of these mandatory days, they can use the app and share their survey and image data.

    The surveys and images uploaded to the app will be evaluated by the researcher and reviewed by a clinician. Retakes will be requested for photos that are not of sufficient quality for evaluation. Clinical recommendations after review will be based on the patient's reported symptoms, and the wound images will provide additional information on this topic. One month after the cesarean section, all participants will be contacted by the researcher. They will be asked about the current status of their wounds and a patient satisfaction survey will be administered.

Study groups in NCT07205939
Study groupRoleWhat they receive
Standard Care (Usual Care) - routine postpartum wound care instructions and scheduled follow-up.No interventionNot described
Mobile App Telemonitoring + Standard CareExperimentalNot described
Receives: Device: Mobile Application usage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical Site Infection (SSI) within 30 days (CDC criteria)

    SSI status adjudicated per CDC criteria by a blinded outcomes assessor.

    Measured: 30 days post-cesarean

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start5 Jan 2025
  3. Primary completion20 Jan 2026
  4. Study completion5 Feb 2026

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07205939
Sponsor's protocol ID
ISU-CS-23-277
Status last verified
Feb 2026
First submitted
25 Sep 2025
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: e are evaluating the feasibility of sharing a de-identified individual participant dataset excluding raw wound photographs, pending final ethics approval and explicit consent language. If feasible, the dataset would include group assignment, baseline characteristics, primary and secondary outcomes, and derived image variables (e.g., erythema/drainage present vs absent). Direct identifiers will be removed, dates will be shifted, and rare categories top-coded. This record will be updated prior to publication of the primary results.

Publications

  • Rochon M, Jawarchan A, Fagan F, Otter JA, Tanner J. Image-based digital post-discharge surveillance in England: measuring patient enrolment, engagement, clinician response times, surgical site infection, and carbon footprint. J Hosp Infect. 2023 Mar;133:15-22. doi: 10.1016/j.jhin.2023.01.001. Epub 2023 Jan 13.

    PubMed 36642336
  • McLean KA, Sgro A, Brown LR, Buijs LF, Daines L, Potter MA, Bouamrane MM, Harrison EM. Evaluation of remote digital postoperative wound monitoring in routine surgical practice. NPJ Digit Med. 2023 May 5;6(1):85. doi: 10.1038/s41746-023-00824-9.

    PubMed 37147462
  • McLean KA, Mountain KE, Shaw CA, Drake TM, Pius R, Knight SR, Fairfield CJ, Sgro A, Bouamrane M, Cambridge WA, Lyons M, Riad A, Skipworth RJE, Wigmore SJ, Potter MA, Harrison EM; TWIST Collaborators. Remote diagnosis of surgical-site infection using a mobile digital intervention: a randomised controlled trial in emergency surgery patients. NPJ Digit Med. 2021 Nov 18;4(1):160. doi: 10.1038/s41746-021-00526-0.

    PubMed 34795398

Questions about this trial

What is this clinical trial studying?

A study testing Mobile Application usage in people with Surgical Infection and Cesarean Section Wound, run by Sibel Bulut Haklı at 1 site in Turkey (Türkiye).

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 5 inclusion and 2 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 3 Mar 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 Turkey (Türkiye). 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?

Surgical Site Infection (SSI) within 30 days (CDC criteria) (time frame: 30 days post-cesarean). 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 NCT07205939, which also lists 3 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 3 Mar 2026.

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