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

N/AEnrolling By InvitationNCT07395518

Queen Savang Vadhana Memorial Hospital, Thailand86 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Surgical Site Infection (SSI)

Interventions

Radivac drainDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Savang vadhana Memmorial Hospital

Chon Buri, Changwat Chon Buri, Thailand

Outcomes

Primary Outcomes

Primary outcome

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

Time frame: 14 days

Secondary Outcomes

Length of hospital stay

Time frame: 14 days

Data from ClinicalTrials.gov

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