NCT07395518

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Surgical Site Infection (SSI)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-07-31
• Completion: 2026-03-31
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Thailand