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

NCT07395518 | Enrolling By Invitation DMC

• 1 other identifier: 014/2568
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgical Site Infection (SSI)

Keywords

Cesarean section wound infection; Subcutaneous incision drainage; Elective and Emergency Cesarean section wound infection.

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  To compare the incidence of surgical site infection after cesarean section in pregnant women with and without subcutaneous wound drainage.

  14 days

Secondary Outcomes (1)

• Length of hospital stay

  14 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Pregnant women undergoing cesarean section with placement of a subcutaneous wound drain.

Device: Radivac drain

Control group

NO INTERVENTION

Pregnant women undergoing cesarean section without placement of a subcutaneous wound drain.

Interventions

Radivac drain DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang vadhana Memmorial Hospital

Chon Buri, Changwat Chon Buri, 20110, Thailand

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized controlled trial (RCT) in which participants are divided into two groups: Block randomization will be used, employing a block size of four to ensure a balanced number of participants in both groups. Intervention Group: Pregnant women undergoing cesarean section with placement of a subcutaneous wound drain. Control Group: Pregnant women undergoing cesarean section without placement of a subcutaneous wound drain.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 9, 2026
• Study Start: June 1, 2025
• Primary Completion: July 31, 2025
• Study Completion: March 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

TH (1)