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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
189

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings