Surgical Site InfectionNCT06063629
Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Surgical Wound After Abdominal Surgery
A study testing Subcutaneous drain and No drain in people with Surgical Site Infection, run by Queen Savang Vadhana Memorial Hospital, Thailand.
Trial summary
Surgical site infections (SSI) pose a common challenge in the field of surgery. Current evidence and literature do not provide clear consensus whether the use of subcutaneous drainage will help reduce the incidence of SSI in patients who underwent abdominal surgery, especially in wounds that are categorized as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Subcutaneous drain and No drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age equal or over 18 years old
- Admitted to Queen Savang Vadhana Memorial Hospital
- Receive abdominal surgery and were classified as class 3 or 4 wound
Who cannot join
- Patients who undergo operation for ostomy
- Patients who do not receive appropriate antibiotics
- Patients who undergo operation before full recover of prior operation
- Patients who undergo laparoscopic operation
- Pregnant women
- Patients who had history of prior radiation therapy at abdomen
- Patient with immunocompromised status
- Patient with chronic skin disease
About this study
Official title: Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Abdominal Surgery Wound Class III and IV
Surgical site infections (SSI) pose a common challenge in the field of surgery. Current evidence and literature do not provide clear consensus whether the use of subcutaneous drainage will help reduce the incidence of SSI in patients who underwent abdominal surgery, especially in wounds that are categorized as contaminated (class 3) or dirty/infected (class 4).
The objective of this clinical study is to compare the rate of surgical site infection in contaminated and dirty/infected surgical wounds among patients whose wounds are inserted with subcutaneous drainage and patients who are not inserted with subcutaneous drainage.
Read the detailed description
This study is a randomized, controlled and open study, where participants who undergo abdominal surgery will be randomly allocated into two groups: (i) patients whose wounds are inserted with subcutaneous negative pressure drain and (ii) patients whose wounds are not inserted with subcutaneous negative pressure drain.
The participants in this study will know the details about the presence of their drain placement after the operation. If the patient was assigned to the drain group, the drain will be placed for five days or until there are no content observed in the drain. The primary outcome of this study is the occurrence of SSI, which will be tracked up to 30 days post-operation. The patient in both groups will also be evaluated by the surgeons at day 3, 5, 7, 14 and 30 post-operation for signs and complications of SSI. In situation where the patients are discharged prior to the date of evaluation, the patients will be scheduled for evaluation during the follow-up visits.
If SSI is detected in the drain group prior to removal, the drain will be removed and the patient will be treated with wet dressing combined with antibiotics. Complications of SSI will also be noted. Patient's data on demographic, medical history, clinical presentation, details of operation, and other laboratory findings will also be collected to investigate for risk factors for development of SSI between each group.
- Conditions
- Surgical Site Infection
- Being tested
- Subcutaneous drain, No drain
- 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.
Subcutaneous drainProcedure or surgery
The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study.
No drainProcedure or surgery
No drain will be inserted into patients allocated to this group
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous drain | Experimental | The drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study. Receives: Procedure: Subcutaneous drain |
| No drain | Other | No drain will be inserted into the surgical wound in this arm. Receives: Procedure: No drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Surgical Site Infection (SSI)
The rate of SSI will be compared between the drain and no drain group
Measured: Post operation day 3
Rate of Surgical Site Infection (SSI)
The rate of SSI will be compared between the drain and no drain group
Measured: Post operation day 5
Rate of Surgical Site Infection (SSI)
The rate of SSI will be compared between the drain and no drain group
Measured: Post operation day 7
Rate of Surgical Site Infection (SSI)
The rate of SSI will be compared between the drain and no drain group
Measured: Post operation day 14
Rate of Surgical Site Infection (SSI)
The rate of SSI will be compared between the drain and no drain group
Measured: Post operation day 30
Secondary outcomes (5)
Length of hospital stay
The length of hospital stay will be compared between drain and no drain group
Measured: Post operation day 3
Length of hospital stay
The length of hospital stay will be compared between drain and no drain group
Measured: Post operation day 5
Length of hospital stay
The length of hospital stay will be compared between drain and no drain group
Measured: Post operation day 7
Length of hospital stay
The length of hospital stay will be compared between drain and no drain group
Measured: Post operation day 14
Length of hospital stay
The length of hospital stay will be compared between drain and no drain group
Measured: Post operation day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Jun 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies 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
- Minimization randomization
- Masking
- None (open label)
- Enrolment
- 180 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
- NCT06063629
- Sponsor's protocol ID
- 030/2565
- Status last verified
- Apr 2024
- First submitted
- 22 Sep 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Abdominal Surgery Wound Class III and IV
- ClinicalTrials.gov ID
- NCT06063629
- Acronym / sponsor ID
- 030/2565
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 2 Oct 2023 (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.
Surgical site infections (SSI) pose a common challenge in the field of surgery. Current evidence and literature do not provide clear consensus whether the use of subcutaneous drainage will help reduce the incidence of SSI in patients who underwent abdominal surgery, especially in wounds that are categorized as contaminated (class 3) or dirty/infected (class 4).
The objective of this clinical study is to compare the rate of surgical site infection in contaminated and dirty/infected surgical wounds among patients whose wounds are inserted with subcutaneous drainage and patients who are not inserted with subcutaneous drainage.
Detailed description
This study is a randomized, controlled and open study, where participants who undergo abdominal surgery will be randomly allocated into two groups: (i) patients whose wounds are inserted with subcutaneous negative pressure drain and (ii) patients whose wounds are not inserted with subcutaneous negative pressure drain.
The participants in this study will know the details about the presence of their drain placement after the operation. If the patient was assigned to the drain group, the drain will be placed for five days or until there are no content observed in the drain. The primary outcome of this study is the occurrence of SSI, which will be tracked up to 30 days post-operation. The patient in both groups will also be evaluated by the surgeons at day 3, 5, 7, 14 and 30 post-operation for signs and complications of SSI. In situation where the patients are discharged prior to the date of evaluation, the patients will be scheduled for evaluation during the follow-up visits.
If SSI is detected in the drain group prior to removal, the drain will be removed and the patient will be treated with wet dressing combined with antibiotics. Complications of SSI will also be noted. Patient's data on demographic, medical history, clinical presentation, details of operation, and other laboratory findings will also be collected to investigate for risk factors for development of SSI between each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Minimization randomization
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous drain | Experimental | Procedure: Subcutaneous drainThe drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study. |
| No drain | Other | Procedure: No drainNo drain will be inserted into the surgical wound in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age equal or over 18 years old
- Admitted to Queen Savang Vadhana Memorial Hospital
- Receive abdominal surgery and were classified as class 3 or 4 wound
Key exclusion criteria (8 listed)
- Patients who undergo operation for ostomy
- Patients who do not receive appropriate antibiotics
- Patients who undergo operation before full recover of prior operation
- Patients who undergo laparoscopic operation
- Pregnant women
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 |
|---|---|---|
| Subcutaneous drainThe drain will be inserted into subcutaneous layer of the surgical wound. Redivac drain will be used in this study. | Procedure or surgery | Subcutaneous drain |
| No drainNo drain will be inserted into patients allocated to this group | Procedure or surgery | No drain |
Primary outcome
Rate of Surgical Site Infection (SSI)
Time frame: Post operation day 3
The rate of SSI will be compared between the drain and no drain group
Rate of Surgical Site Infection (SSI)
Time frame: Post operation day 5
The rate of SSI will be compared between the drain and no drain group
Rate of Surgical Site Infection (SSI)
Time frame: Post operation day 7
The rate of SSI will be compared between the drain and no drain group
Rate of Surgical Site Infection (SSI)
Time frame: Post operation day 14
The rate of SSI will be compared between the drain and no drain group
Rate of Surgical Site Infection (SSI)
Time frame: Post operation day 30
The rate of SSI will be compared between the drain and no drain group
5 secondary outcomes
Length of hospital stay
Time frame: Post operation day 3
Length of hospital stay
Time frame: Post operation day 5
Length of hospital stay
Time frame: Post operation day 7
Length of hospital stay
Time frame: Post operation day 14
Length of hospital stay
Time frame: Post operation day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous drain and No drain in people with Surgical Site Infection, run by Queen Savang Vadhana Memorial Hospital, 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Rate of Surgical Site Infection (SSI) (time frame: Post operation day 3). The study lists 5 primary outcomes in all. 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 4 Apr 2024.