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Evaluation of Surgical Site Infection After Cesarean Section

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07205939
Enrollment
216
Registered
2025-10-03
Start date
2025-01-05
Completion date
2026-02-05
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Wound, Surgical Infection

Keywords

mobile application, cesarean section, surgical site infection

Brief 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. 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.

Interventions

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.

Sponsors

Sibel Bulut Haklı
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Surgical Site Infection (SSI) within 30 days (CDC criteria)30 days post-cesareanSSI status adjudicated per CDC criteria by a blinded outcomes assessor.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORSİBEL BULUT HAKLI

Istinye University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026