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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radivac drain.
- Who it may be relevant to
- Registry conditions: Surgical Site Infection (SSI). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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
- 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 Redi
Primary outcome measures
- Primary outcome [Time frame: 14 days]
Secondary outcome measures (1)
- Length of hospital stay [Time frame: 14 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Thailand · 1 center
- Queen Savang vadhana Memmorial Hospital — Chon Buri
Identifiers
NCT: NCT07395518 · 014/2568