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

NCT07517718 | Completed DMC

• 1 other identifier: 2024-790
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection (SSI); Cesarean Section Wound

Outcome Measures

Primary Outcomes (1)

• Incidence of surgical site infection

  Assessment of surgical site infection according to standard clinical criteria following cesarean section in the study groups.

  10 days

Secondary Outcomes (1)

• Wound complications

  6 weeks

Study Arms (3)

Subcutaneous Drain group

EXPERIMENTAL

A Drain is put subcutaneously to drain any excess fluid

Procedure: Subcutaneous Drain

Wound irrigation group

ACTIVE COMPARATOR

The wound is irrigated with Normal saline before wound closure intraoperatively.

Procedure: Normal Saline

Only Subcutaneous closure

NO INTERVENTION

Subcutaneous closure with vicryl with no additional intervention.

Interventions

Subcutaneous Drain PROCEDURE

Subcutaneous Drain is put before wound closure

Also known as: Drain insertion subcutaneously

Subcutaneous Drain group

Normal Saline PROCEDURE

wound irrigation with Normal Saline before wound closure

Also known as: Normal saline (NS) 0.9%

Wound irrigation group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female, obese, Pregnant patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obese Pregnant women who attend for cesarean section.
• Aged 18 to 50 years old.
• BMI ≥ 30 kg/m2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University, Maternity Hospital

Cairo, Egypt

Location

Related Publications (8)

• 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.

  BACKGROUND

• Anfinan N, Sait KH. Appropriate Management of Subcutaneous Tissue of Midline Abdominal Incisions. Cureus. 2020; 12(1):e6549.

  BACKGROUND

• 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.

  BACKGROUND

• ProCon.org. Global obesity levels (2020). Available online at: https://obesity.procon.org/global-obesity-levels/ (accessed June 28, 2020)

  BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: January 9, 2025
• Primary Completion: July 15, 2025
• Study Completion: November 1, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)