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临床试验/NCT07205939
NCT07205939已完成不适用

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

Sibel Bulut Haklı1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2025年1月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
216
试验地点
1
主要终点
Surgical Site Infection (SSI) within 30 days (CDC criteria)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Standard Care (Usual Care) - routine postpartum wound care instructions and scheduled follow-up.

No Intervention

Mobile App Telemonitoring + Standard Care

Experimental

干预措施: Mobile Application usage (Device)

结局指标

主要结局

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

时间窗: 30 days post-cesarean

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

次要结局

未报告次要终点

研究者

发起方
Sibel Bulut Haklı
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sibel Bulut Haklı

PhD Candidate

Istinye University

研究点 (1)

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