Surgical Site Infection (SSI)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
A study testing Radivac drain in people with Surgical Site Infection (SSI), run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Site Infection (SSI)
- What is being tested?
- Radivac drain
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2025to 29 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Queen Savang vadhana Memmorial Hospital
Chon Buri, Changwat Chon Buri, 20110
About this study
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
Read the 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)
- Being tested
- Radivac drain
- Keywords
- Cesarean section wound infection, Subcutaneous incision drainage, Elective and Emergency Cesarean section wound infection.
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Pregnant women undergoing cesarean section with placement of a subcutaneous wound drain. Receives: Device: Radivac drain |
| Control group | No intervention | Pregnant women undergoing cesarean section without placement of a subcutaneous wound drain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
To compare the incidence of surgical site infection after cesarean section in pregnant women with and without subcutaneous wound drainage.
Measured: 14 days
Secondary outcomes (1)
Length of hospital stay
Length of hospital stay
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Jun 2025
- Primary completion1 May 2026
- Study completion29 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection (SSI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395518
- Sponsor's protocol ID
- 014/2568
- Status last verified
- Aug 2026
- First submitted
- 13 Jan 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data was save in form of microsoft excel spreadsheet and SPSS file
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07395518
- Acronym / sponsor ID
- 014/2568
- Conditions
- Surgical Site Infection (SSI)
- Keywords
- Cesarean section wound infection, Subcutaneous incision drainage, Elective and Emergency Cesarean section wound infection.
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 29 Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Radivac drainPregnant women undergoing cesarean section with placement of a subcutaneous wound drain. |
| Control group | No intervention | –Pregnant women undergoing cesarean section without placement of a subcutaneous wound drain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radivac drainIn 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. | Device | Intervention group |
Primary outcome
Primary outcome
Time frame: 14 days
To compare the incidence of surgical site infection after cesarean section in pregnant women with and without subcutaneous wound drainage.
1 secondary outcome
Length of hospital stay
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided. Data was save in form of microsoft excel spreadsheet and SPSS file
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radivac drain in people with Surgical Site Infection (SSI), run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.