Surgical Site Infection (SSI)
Conditions
Keywords
Cesarean section wound infection, Subcutaneous incision drainage, Elective and Emergency Cesarean section wound infection.
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
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.
Interventions
DEVICERadivac 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.
Sponsors
Queen Savang Vadhana Memorial Hospital, Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome | 14 days | To compare the incidence of surgical site infection after cesarean section in pregnant women with and without subcutaneous wound drainage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 14 days | Length of hospital stay |
Countries
Thailand
Outcome results
None listed