CompletedNot Applicable

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

Egypt189 participantsStarted 2025-01-09

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of surgical site infection

Timeframe: 10 days

Trial details

NCT IDNCT07517718

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-15

View on ClinicalTrials.gov More Surgical Site Infection (SSI) trials