A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital

February 1, 2026 updated by: Queen Savang Vadhana Memorial Hospital, Thailand
To study and compare the incidence of surgical site infection after cesarean section in pregnant women with subcutaneous wound drainage and those without subcutaneous wound drainage at Queen Savang Vadhana Memorial Hospital, Sriracha. Chonburi Thailand

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled trial (RCT) designed to compare the incidence of surgical site infection after cesarean section between patients who receive subcutaneous wound drainage (Radivac drain) and those who do not. Postoperative wound follow-up will be conducted on postoperative days 3, 7, and 14.

Participants will be randomly assigned into two groups, with the control group consisting of pregnant women undergoing cesarean section at Queen Savang Vadhana Memorial Hospital, Sriracha. Data will be collected on surgical site infection, pain, postoperative complications, and length of hospital stay.

Study Type

Interventional

Enrollment (Estimated)

86

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

  • Thailand
    • Changwat Chon Buri
      • Chon Buri, Changwat Chon Buri, Thailand, 20110
        • Queen Savang vadhana Memmorial 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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Able to communicate in Thai
  • Undergoing cesarean section, both elective and emergency procedures
  • Subcutaneous fat thickness ≥ 4 cm, measured preoperatively using a standardized ultrasound technique
  • Able to return for postpartum follow-up at Somdech Phra Boromrajthevi Hospital, Sriracha
  • Willing to participate in the study and able to provide written informed consent

Exclusion Criteria:

  • Pregnant women with chronic immunosuppressive conditions, such as systemic lupus erythematosus (SLE), HIV infection, severe anemia (Hb < 10.0 g/dL), or uncontrolled diabetes
  • Presence of skin disease or skin infection at the abdominal surgical site
  • Evidence of infection prior to cesarean section
  • Abnormal bleeding disorders requiring specialized treatment
  • History of allergy to, or complications from, the use of wound drainage systems
  • Refusal to participate in the study

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Pregnant women undergoing cesarean section with placement of a subcutaneous wound drain.
Device: Radivac drain
In the intervention group, a subcutaneous wound drain is placed using a closed suction Redivac drain (10-14 French). The drain is inserted into the subcutaneous layer above the surgical incision through a skin exit site located 2-3 cm from the wound edge, avoiding visible vessels to reduce bleeding. A trocar is used to guide placement, ensuring the drain lies transversely beneath and covers the entire length of the incision. The drain is secured to the skin with silk sutures, connected to a Redivac suction system to apply negative pressure, and covered with a sterile dressing after skin closure to reduce the risk of contamination.
No Intervention: Control group
Pregnant women undergoing cesarean section without placement of a subcutaneous wound drain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome
Time Frame: 14 days
To compare the incidence of surgical site infection after cesarean section in pregnant women with and without subcutaneous wound drainage.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 14 days
Length of hospital stay
14 days

Collaborators and Investigators

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

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

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)

June 1, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

February 1, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 014/2568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data was save in form of microsoft excel spreadsheet and SPSS file

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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