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

April 9, 2026 updated by: Ain Shams University

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University, Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subcutaneous Drain group
A Drain is put subcutaneously to drain any excess fluid
Procedure: Subcutaneous Drain
Subcutaneous Drain is put before wound closure
Other Names:
  • Drain insertion subcutaneously
Active Comparator: Wound irrigation group
The wound is irrigated with Normal saline before wound closure intraoperatively.
Procedure: Normal Saline
wound irrigation with Normal Saline before wound closure
Other Names:
  • Normal saline (NS) 0.9%
No Intervention: Only Subcutaneous closure
Subcutaneous closure with vicryl with no additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound complications
Time Frame: 6 weeks
Dehiscence of wound, cosmetic evaluation, need for surgical intervention.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Mahmoud M. Ghaleb, Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University
  • Principal Investigator: Waleed H. Ahmed, Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University
  • Principal Investigator: Mohammad A. Alzeiny, Department of Obstetrics and Gynecology, faculty of Medicine, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Gül DK. The role of saline irrigation of subcutaneous tissue in preventing surgical site complications during cesarean section: A prospective randomized controlled trial. J Surg Med. 2021;5(1):8-11.
  • Anfinan N, Sait KH. Appropriate Management of Subcutaneous Tissue of Midline Abdominal Incisions. Cureus. 2020; 12(1):e6549.
  • Słabuszewska-Jóźwiak A, Szymański JK, Jóźwiak Ł, Sarecka-Hujar B. A Systematic Review and Meta-Analysis of Wound Complications after a Caesarean Section in Obese Women. J Clin Med. 2021; 10(4):675.
  • ProCon.org. Global obesity levels (2020). Available online at: https://obesity.procon.org/global-obesity-levels/ (accessed June 28, 2020)
  • Centers for Disease Control and Prevention. National Healthcare Safety Network (NHSN) Patient Safety Component Manual. 2021 https:// www. cdc. gov/ nhsn/ pdfs/ validation/2021/pcsmanual_2021-508.pdf. Accessed August 10, 2022
  • Gomaa K, Abdelraheim AR, El Gelany S, Khalifa EM, Yousef AM, Hassan H. Incidence, risk factors and management of post cesarean section surgical site infection (SSI) in a tertiary hospital in Egypt: a five year retrospective study. BMC Pregnancy Childbirth. 2021; 21(1):634.
  • Wahdan M, Hakim S, El Gaafary M, Sos D, Wassif G, Hussein W, Mokhtar A, Hussein A, El Awady M, Rady M, Anwar W. Rising trends in Caesarean section in 6 Egyptian governorates. Eastern Mediterranean Health Journal. 2022 May 1;28(5).
  • Angolile CM, Max BL, Mushemba J, Mashauri HL. Global increased cesarean section rates and public health implications: A call to action. Health Sci Rep. 2023; 6(5):e1274.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2025

Primary Completion (Actual)

July 15, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-790

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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