Skip to main content
OpenTrials
Completed

NCT Number: NCT07517718

Subcutaneous Drain Versus Wound Irrigation by Normal Saline for Prevention of Surgical Site Infection Following Caesarean Section in Obese Patients.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Site Infection (SSI) Cesarean Section Wound Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University, Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subcutaneous Drain

Procedure

Subcutaneous Drain is put before wound closure

Other names: Drain insertion subcutaneously

Normal saline

Procedure

wound irrigation with Normal Saline before wound closure

Other names: Normal saline (NS) 0.9%

Primary outcomes

  1. 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

  1. Wound complications

    Time frame: 6 weeks

    Dehiscence of wound, cosmetic evaluation, need for surgical intervention.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.