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).
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.
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.
- Conditions
- Surgical Infection, Cesarean Section Wound
- 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 group | Role | What they receive |
|---|---|---|
| Standard Care (Usual Care) - routine postpartum wound care instructions and scheduled follow-up. | No intervention | Not described |
| Mobile App Telemonitoring + Standard Care | Experimental | Not described Receives: Device: Mobile Application usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted3 Oct 2025
- Study start5 Jan 2025
- Primary completion20 Jan 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel Bulut Haklı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sibel Bulut Haklı, Istinye University
- Investigators
- SİBEL BULUT HAKLI, Principal investigator, Istinye University
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 36642336McLean 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 37147462McLean 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Assessment of the Permanent Site After Cesarean Section: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07205939
- Acronym / sponsor ID
- ISU-CS-23-277
- Conditions
- Surgical Infection, Cesarean Section Wound
- Keywords
- mobile application, cesarean section, surgical site infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Sibel Bulut HaklıUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 3 Oct 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.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care (Usual Care) - routine postpartum wound care instructions and scheduled follow-up. | No intervention | – |
| Mobile App Telemonitoring + Standard Care | Experimental | Device: Mobile Application usage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
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 |
|---|---|---|
| Mobile Application usageAlso: SurgiMommaArticipants 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. | Device | Mobile App Telemonitoring + Standard Care |
Primary outcome
Surgical Site Infection (SSI) within 30 days (CDC criteria)
Time frame: 30 days post-cesarean
SSI status adjudicated per CDC criteria by a blinded outcomes assessor.
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 3 Mar 2026.
- Results publication: PubMed 36642336Rochon 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.
- Results publication: PubMed 37147462McLean 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.
- Results publication: PubMed 34795398McLean 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.
- Individual participant dataSharing planned: 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.
Related trials for Surgical Infection
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Recruiting
Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.
Osteomyelitis
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
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.
SİBEL BULUT HAKLI principal investigator
Istinye 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 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.