Subcutaneous Drain Versus Wound Irrigation by Normal Saline for Prevention of Surgical Site Infection Following Caesarean Section in Obese Patients: A Prospective Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 189
- Locations
- 1
- Primary Endpoint
- Incidence of surgical site infection
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts 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 type
- •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.
Arms & Interventions
Subcutaneous Drain group
A Drain is put subcutaneously to drain any excess fluid
Intervention: Subcutaneous Drain (Procedure)
Wound irrigation group
The wound is irrigated with Normal saline before wound closure intraoperatively.
Intervention: Normal Saline (Procedure)
Only Subcutaneous closure
Subcutaneous closure with vicryl with no additional intervention.
Outcomes
Primary Outcomes
Incidence of surgical site infection
Time Frame: 10 days
Assessment of surgical site infection according to standard clinical criteria following cesarean section in the study groups.
Secondary Outcomes
- Wound complications(6 weeks)