Cesarean surgical wound. Infection of obstetric surgical wound
Conditions
Interventions
Intervention 1: First intervention group: dressing with amniotic membrane. After the surgery, a part of the patients amniotic membrane corresponding to the size of the surgical incision is removed and
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Age 18-45 years Singleton pregnancy Having a previous plan for cesarean section and elective cesarean section Planned gestational age of at least 36 weeks at the time of delivery Able to provide informed consent Intention to be available for the entire research period and to complete all relevant study steps, including follow-up visits and phone calls Hemoglobin above 10 g/dL at the time of hospitalization
Exclusion criteria
Exclusion criteria: Body mass index greater than or equal to 40 at the time of entering the study Placenta previa or placenta accreta History of intestinal or urological surgery Multiple pregnancy Known or suspected impairment of immunological function, including infection with HIV, hepatitis B or C Use of immunosuppressive drugs, chemotherapy, radiotherapy, or taking systemic corticosteroids in the 4 weeks before surgery. Known tobacco or drug use Any condition that, in the opinion of the investigator, may pose a risk to the health of the participant or interfere with the evaluation of the study objectives History of keloid formation Participation in another clinical trial in the last three months Any serious cardiovascular, pulmonary, hepatic, renal, digestive, hematologic, endocrine, metabolic, neurological and psychological diseases Frequent vaginal examinations Emergency cesarean section Chorioamnionitis or other systemic infections at the time of presentation for caesarean section, including evidence of subabdominal skin infection (e.g. fungal infection)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing score according to physician's point of view. Timepoint: On days 10 and 28 after surgery. Method of measurement: Using the The Patient and Observer Scar Assessment Scale: POSAS questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of pain at the site of the surgical wound. Timepoint: 4, 12, 24, and 36 hours after surgery and days 10 and 28 after surgery. Method of measurement: Visual Analogue Scale.;Surgical wound infection. Timepoint: 4, 12, 24, and 36 hours after surgery and days 10 and 28 after surgery. Method of measurement: According to the doctor's diagnosis.;Wound healing score according to patient's point of view. Timepoint: On days 10 and 28 after surgery. Method of measurement: Using the The Patient and Observer Scar Assessment Scale: POSAS questionnaire.;Surgical wound infection. Timepoint: 36 hours after surgery and days 10 and 28 after surgery. Method of measurement: According to the doctor's diagnosis.;Severity of pain at the site of the surgical wound. Timepoint: 4, 12, 24, and 36 hours after surgery and days 10 and 28 after surgery. Method of measurement: Visual Analogue Scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmeneh Abiri
Tehran University of Medical Sciences
Outcome results
None listed