Surgical Site InfectionNCT05865821
Protocol Effect of Negative Pressure Drain to Reducing Surgical Site Infection in Surgical Wound of Abdominal Surgery
A study testing Negative pressure drainage and No pressure drain in people with Surgical Site Infection, run by Mahidol University at 1 site in Thailand.
Trial summary
Surgical site infection (SSI) is one of main complication in surgery. It usually occurs within 30 days post operation. The superficial SSI is an infection of skin and subcutaneous layer, clinically presented by pus oozing. Furthermore, seroma hematoma and wound dehiscence are also clinical signs of superficial SSI. 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?
- Negative pressure drainage and No pressure drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteThailand
- Study dates
- 15 Apr 2023to 30 Mar 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
- Patients undergoing intra-abdominal surgery on the upper and lower gastrointestinal tract, pancreas and biliary tract.
- Aged 18 years or older
- Be in good health and full of consciousness.
- Willing to participate in the research study project by signing
Who cannot join
- Patients with thrombocytopenia thrombocytopenia or coagulation disorder
- The study participant refuses or withdraws from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol Effect of Negative Pressure Drain to Reducing Surgical Site Infection in Clean-contaminated and Contaminated Surgical Wound of Abdominal Surgery
Surgical site infection (SSI) is one of main complication in surgery. It usually occurs within 30 days post operation. The superficial SSI is an infection of skin and subcutaneous layer, clinically presented by pus oozing. Furthermore, seroma hematoma and wound dehiscence are also clinical signs of superficial SSI.
Nowadays, there are studies which report methods reducing SSI by placing negative pressure drain within surgical wound. It can reduce serum in subcutaneous layer which is found in every surgical wound, especially in clean-contaminated and contaminated wound. Many studies show that placing negative pressure drainage within a surgical wound can reduce superficial SSI and decrease hospital length of stay by comparing with the control group.
The objective in this study to compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage.
Read the detailed description
This study is a randomized controlled trial, double-blinded and performs in the patient who underwent intra-abdominal surgery. the investigators collect the data at the department of surgery, Ramathibodi hospital. This study randomized the volunteer patient into 2 groups as follow: the patient with placing negative pressure drainage within the surgical wound and the patient without placing negative pressure drainage.
- Randomization To minimize the study bias, the investigators random patient into two groups by the unassociated personnel opens an enclosed envelope after the surgical procedure is completely performed and before the beginning of closing the skin layer.
- Blind process This study does not conceal information about surgical technique and drain placing method. However, the investigators have controlled various surgical procedures to reduce inequality in assessment and bias.
- Negative pressure drainage is a drainage catheter which is placed in surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt or Redivac catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure.
- Surgical site infection (SSI) is infection at surgical wound which happens within 30 days post operatively and in this study will use in term of superficial SSI (pus oozing, cellulitis and wound culture positive) If patients have SSI, the investigators remove the drain from the patients (intervention group) and may total stitch off suture then wet dressing combine with antibiotic. the investigators evaluate and collect data by physical examination at post operation day 3, day 5,day 7 and the day that patient is discharged from hospital. Then investigators follow up the patients at 14 days and 30 days after discharged from hospital.The complication of SSI is seroma, hematoma and wound dehiscence.
- Seroma is the retention of clear fluid in the cavity of the body such as a surgical wound. Typical clinical presentation is fluid oozing from the wound.
- Hematoma is the retention of bloody fluid in the cavity of the body such as a surgical wound. It can be infected which is possible to prevent by stop bleeding intraoperatively and evaluate surgical wound every day.
- Wound dehiscence is partial or total separation of previously approximated wound edges, due to failure of proper wound healing.
In patient case with infected wound and the investigators give antibiotics along with dressing, but does not stitch off suture, we do not include as SSI in this study.
- Conditions
- Surgical Site Infection
- Being tested
- Negative pressure drainage, No pressure drain
- Keywords
- abdominal surgery, surgical site 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.
Negative pressure drainageProcedure or surgery
Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt catheter or Redivac is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure
No pressure drainOther
Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt catheter or Redivac is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure drainage | Active comparator | Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt or Redivac catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure. Receives: Procedure: Negative pressure drainage |
| No pressure drain | Other | no drainage catheter in subcutaneous surgical wound Receives: Other: No pressure drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of SSI
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Measured: post operation day 3
Rate of SSI
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Measured: post operation day 5
Rate of SSI
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Measured: post operation day 7
Rate of SSI
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Measured: post operation day 14
Secondary outcomes (6)
Length of hospital stay
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Measured: day 3
Length of hospital stay
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Measured: day 5
Length of hospital stay
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Measured: day 7
Length of hospital stay
amount of days that the patient stay in hospital since admission date until discharged from the hospital.
Measured: day 14
Score of Quality of life
Quality of life is patient's physical health and mental health. We collect this data by 36-Item Short Form Survey Instrument (SF-36) survey at the 7th day and 14th day after being discharged from the hospital
Measured: day 7
Score of Quality of life
Quality of life is patient's physical health and mental health. We collect this data by 36-Item Short Form Survey Instrument (SF-36) survey at the 7th day and 14th day after being discharged from the hospital
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start15 Apr 2023
- Primary completion6 Mar 2024 (estimated)
- Study completion30 Mar 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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chairat Supsamutchai, MD, Study chair, Ramahibodi hospital, Mahidol UniversityNinnat Fongsupa, MD, Principal investigator, Ramahibodi hospital, Mahidol UniversityNapaphat Poprom, Ph.D, Study director, Ramahibodi hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865821
- Sponsor's protocol ID
- MURA2023/168
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Effect of Negative Pressure Drain to Reducing Surgical Site Infection in Clean-contaminated and Contaminated Surgical Wound of Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05865821
- Acronym / sponsor ID
- MURA2023/168
- Conditions
- Surgical Site Infection
- Keywords
- abdominal surgery, surgical site infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 6 Mar 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 19 May 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 infection (SSI) is one of main complication in surgery. It usually occurs within 30 days post operation. The superficial SSI is an infection of skin and subcutaneous layer, clinically presented by pus oozing. Furthermore, seroma hematoma and wound dehiscence are also clinical signs of superficial SSI.
Nowadays, there are studies which report methods reducing SSI by placing negative pressure drain within surgical wound. It can reduce serum in subcutaneous layer which is found in every surgical wound, especially in clean-contaminated and contaminated wound. Many studies show that placing negative pressure drainage within a surgical wound can reduce superficial SSI and decrease hospital length of stay by comparing with the control group.
The objective in this study to compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage.
Detailed description
This study is a randomized controlled trial, double-blinded and performs in the patient who underwent intra-abdominal surgery. the investigators collect the data at the department of surgery, Ramathibodi hospital. This study randomized the volunteer patient into 2 groups as follow: the patient with placing negative pressure drainage within the surgical wound and the patient without placing negative pressure drainage.
- Randomization To minimize the study bias, the investigators random patient into two groups by the unassociated personnel opens an enclosed envelope after the surgical procedure is completely performed and before the beginning of closing the skin layer.
- Blind process This study does not conceal information about surgical technique and drain placing method. However, the investigators have controlled various surgical procedures to reduce inequality in assessment and bias.
- Negative pressure drainage is a drainage catheter which is placed in surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt or Redivac catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure.
- Surgical site infection (SSI) is infection at surgical wound which happens within 30 days post operatively and in this study will use in term of superficial SSI (pus oozing, cellulitis and wound culture positive) If patients have SSI, the investigators remove the drain from the patients (intervention group) and may total stitch off suture then wet dressing combine with antibiotic. the investigators evaluate and collect data by physical examination at post operation day 3, day 5,day 7 and the day that patient is discharged from hospital. Then investigators follow up the patients at 14 days and 30 days after discharged from hospital.The complication of SSI is seroma, hematoma and wound dehiscence.
- Seroma is the retention of clear fluid in the cavity of the body such as a surgical wound. Typical clinical presentation is fluid oozing from the wound.
- Hematoma is the retention of bloody fluid in the cavity of the body such as a surgical wound. It can be infected which is possible to prevent by stop bleeding intraoperatively and evaluate surgical wound every day.
- Wound dehiscence is partial or total separation of previously approximated wound edges, due to failure of proper wound healing.
In patient case with infected wound and the investigators give antibiotics along with dressing, but does not stitch off suture, we do not include as SSI in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Negative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure.
| Arm | Type | Receives |
|---|---|---|
| Negative pressure drainage | Active comparator | Procedure: Negative pressure drainageNegative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt or Redivac catheter is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure. |
| No pressure drain | Other | Other: No pressure drainno drainage catheter in subcutaneous surgical wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing intra-abdominal surgery on the upper and lower gastrointestinal tract, pancreas and biliary tract.
- Aged 18 years or older
- Be in good health and full of consciousness.
- Willing to participate in the research study project by signing
Key exclusion criteria (2 listed)
- Patients with thrombocytopenia thrombocytopenia or coagulation disorder
- The study participant refuses or withdraws from the study.
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 |
|---|---|---|
| Negative pressure drainageNegative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt catheter or Redivac is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure | Procedure or surgery | Negative pressure drainage |
| No pressure drainNegative pressure drainage is a drainage catheter which is placed in subcutaneous surgical wound for draining fluid such as hematoma, seroma, and pus. In this study the drainage the catheter will be placed in the wound for 5 days and/or removed if fluid content is less than 20 ml per day. Jackson-Pratt catheter or Redivac is used in this study because it is cheap and widespread in all hospitals. The drainage catheter is placed after completion of surgery and before skin closure | Other | No pressure drain |
Primary outcome
Rate of SSI
Time frame: post operation day 3
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Rate of SSI
Time frame: post operation day 5
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Rate of SSI
Time frame: post operation day 7
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
Rate of SSI
Time frame: post operation day 14
To compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage
6 secondary outcomes
Length of hospital stay
Time frame: day 3
Length of hospital stay
Time frame: day 5
Length of hospital stay
Time frame: day 7
Length of hospital stay
Time frame: day 14
Score of Quality of life
Time frame: day 7
Score of Quality of life
Time frame: day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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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.
Chairat Supsamutchai, MD study chair
Ramahibodi hospital, Mahidol University
Ninnat Fongsupa, MD principal investigator
Ramahibodi hospital, Mahidol University
Napaphat Poprom, Ph.D study director
Ramahibodi hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure drainage and No pressure drain in people with Surgical Site Infection, run by Mahidol University 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 4 inclusion and 2 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 19 May 2023. 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?
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 SSI (time frame: post operation day 3). The study lists 4 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 19 May 2023.