Cesarean Section Wound, Surgical Site Infection (SSI)
Conditions
Brief summary
This is a prospective randomized controlled trial conducted at Ain Shams University Maternity Hospital to compare subcutaneous drain versus wound irrigation with normal saline for the prevention of surgical site infection following cesarean section in obese patients. Eligible women were randomly assigned to either subcutaneous drain placement or intraoperative wound irrigation, or subcutaneous skin closure only. The primary outcome was the incidence of surgical site infection, with additional assessment of postoperative wound complications and recovery.
Interventions
PROCEDURESubcutaneous Drain
Subcutaneous Drain is put before wound closure
PROCEDURENormal Saline
wound irrigation with Normal Saline before wound closure
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Obese Pregnant women who attend for cesarean section. * Aged 18 to 50 years old. * BMI ≥ 30 kg/m2.
Exclusion criteria
* Preoperative uncontrolled infection. * Prolonged premature rupture of membranes. * Severe surgical blood loss \>1000ml. * Uncontrolled Pregestational Diabetes mellitus type 1 and type2. * Uncontrolled Gestational Diabetes mellitus. * Uncontrolled Hypertension with pregnancy. * Preeclampsia and Eclampsia, Pregnancy-induced hypertension (PIH). * Chronic medical disorders including chronic kidney disease, chronic hepatitis, chronic autoimmune disease and chronic heart disease. * Anemia with pregnancy. * Patient with Immunodeficiency disorders and patients on immunosuppressive drugs. * Patient with recent history of drug abuse. * Smoker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical site infection | 10 days | Assessment of surgical site infection according to standard clinical criteria following cesarean section in the study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound complications | 6 weeks | Dehiscence of wound, cosmetic evaluation, need for surgical intervention. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMahmoud M. Ghaleb
Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University
PRINCIPAL_INVESTIGATORWaleed H. Ahmed
Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University
PRINCIPAL_INVESTIGATORMohammad A. Alzeiny
Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University
Outcome results
None listed