Surgical Site InfectionsSSINCT06801275
The Effect of Number of Showers With 4% Chlorhexidine Gluconate on Prevention of Surgical Site Infections
A study testing 1 shower with 4% chlorhexidine gluconate and 2 shower with 4% chlorhexidine gluconate in people with Surgical Site Infections and Lumbar Disc Herniation, run by Çanakkale Onsekiz Mart University at 2 sites in Turkey (Türkiye).
Trial summary
Surgical site infections (SSIs) are the most common type of nosocomial infection in surgical departments. Although lumbar disc herniation (LDH), which is one of the common cases in neurosurgery, is a serious problem affecting postoperative SSI, morbidity and mortality, there are not enough studies on its prevention in… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infections, Lumbar Disc Herniation
- What is being tested?
- 1 shower with 4% chlorhexidine gluconate and 2 shower with 4% chlorhexidine gluconate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 15 Dec 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to communicate verbally
Who cannot join
- Patients with diabetes mellitus side disease, pylolidal cyst surgery, any surgical history from the lumbar region and patients who will undergo lumbar disc hernia stabilisation surgery will not be included.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Çanakkale on Sekiz Mart University
Çanakkale, Merkez, 17100
Çanakkale on Sekiz Mart Üniversity
Çanakkale, Merkez, 17100
About this study
Official title: The Effect of Number of Showers With 4% Chlorhexidine Gluconate Before Lumbar Disc Herniation Surgery on Prevention of Postoperative Surgical Site Infections: A Single-Blind Randomized Controlled Trial
Surgical site infections (SSIs) are the most common type of nosocomial infection in surgical departments.
Although lumbar disc herniation (LDH), which is one of the common cases in neurosurgery, is a serious problem affecting postoperative SSI, morbidity and mortality, there are not enough studies on its prevention in the literature.
Read more
In the literature, there are studies on showering with chlorhexidine or other antiseptic solutions in the preoperative period to prevent SSI, but there is no study on whether the number of showers performed in the preoperative period is effective on SSI.
In this study, the effect of showering with 4% chlorhexidine gluconate before lumbar disc herniation surgery on postoperative surgical site infections will be examined. It is aimed to compare the effect of douching with 4% Chlorhexidine Gluconate before lumbar disc hernia surgery on surgical site infections. Since there are not enough studies in the literature, this study is an innovative study. In this study, it is thought that washing the surgical site with antiseptic soap containing 4% Chlorhexidine Gluconate before LDH surgery will have an effect on surgical site infections.
Read the detailed description
Lumbar disc herniation surgery is performed in two ways: open discectomy and microdiscectomy. In open discectomy, the skin incision is made large enough to expose the lamina and to create an area where the retractor can work with the naked eye. After the lamina is exposed, the correct distance is determined by feeling the sacrum with the fingers. Scopy assistance may be required in suspicious cases. Bone tissue is removed from the lamina to the beginning of the ligamentum flavum without damaging the facet joints. Then the ligament is removed and discectomy is performed by pushing the dura and nerve root inwards. In microdiscectomy, a smaller incision (1.5-2 cm) is made. Special retractors or tubes are inserted. Partial hemilaminotomy and discectomy are performed using microscope and microsurgical instruments.
Although the incidence of SSI after LDH surgery is not known with certainty, patients usually have various potential risk factors for CAI such as advanced age, malnutrition due to loss of appetite, and steroid use. All surgical patients are at risk for developing SSI. For patients, SSI can cause pain and discomfort, financial losses, and impaired quality of life. These infections can lead from a simple incision site abscess with purulent discharge to a complex infection that can contribute to a life-threatening condition and possible morbidity. Therefore, accurate monitoring of SSI and confirmation of the diagnosis of SSI are very important and vital for patients.
The main causative microorganisms of SSI in the preoperative period are gram-positive cocci, which are common bacterial colonies of the skin. Therefore, although WHO recommends showering with normal or antiseptic soap before surgical intervention, it is thought that the use of antiseptic soap will be more effective to destroy a larger number of skin pathogens both before and during surgical intervention.. For this reason, it was deemed appropriate to wash the surgical areas of the patients with antiseptic soap containing 4% chlorhexidine gluconate before surgery.
In the literature, there are studies showing that many factors related to the perioperative process and surgical procedure increase the risk of developing SSI. Among these, there are studies showing that bathing with an antimicrobial agent before surgical intervention reduces the overall bacterial load in the skin's own flora, thus reducing the risk of SSI.
Although there are evidence-based recommendations and some improved care practices to prevent SSI in the literatüre, there is no standardised practice with proven efficacy today. This study is a randomised controlled experimental design and requires a team approach consisting of physicians and nurses in line with the existing evidence recommendations. Therefore, it is thought that showering the operation area with antiseptic soap containing 4% Chlorhexidine Gluconate before lumbar disc herniation surgery will be effective in reducing SSI.
- Conditions
- Surgical Site Infections, Lumbar Disc Herniation
- Being tested
- 1 shower with 4% chlorhexidine gluconate, 2 shower with 4% chlorhexidine gluconate
- Keywords
- surgical site infections, 4% Chlorhexidine Gluconate
- Medical subject headings
- Surgical Wound Infection, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 shower with 4% chlorhexidine gluconateOther
Also called They will be provided to shower with 4% chlorhexidine gluconate once on the night before surgery.
Comparison of the effect of showering once with 4% Chlorhexidine Gluconate before lumbar disc herniation surgery on surgical site infections
2 shower with 4% chlorhexidine gluconateOther
Also called showering with 4% chlorhexidine gluconate twice, the night before and the morning of surgery
Comparison of the effect of showering twice with 4% Chlorhexidine Gluconate before lumbar disc herniation surgery on surgical site infections
| Study group | Role | What they receive |
|---|---|---|
| The effect of 1 shower with 4% chlorhexidine gluconate on surgical site infections | Experimental | Patients will be showered with 4% chlorhexidine gluconate 1 time on the night before surgery. Receives: Other: 1 shower with 4% chlorhexidine gluconate |
| The effect of 2 shower with 4% chlorhexidine gluconate on surgical site infections | Other | patients will be provided to shower with 4% chlorhexidine gluconate twice, the night before and the morning of the operation. Receives: Other: 2 shower with 4% chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical site infection
Following the surgical intervention, the surgical site will be monitored for purulent discharge, abscess or cellulitis for 30 days. The patients will be followed up by the investigator and the specialist physician in the clinic until discharge and by the investigator after discharge. In the postoperative period, purulent discharge, abscess or cellulitis that develops in the surgical site within 30 days following the surgical intervention will be defined as SSI with the approval of the specialist physician.
Measured: 30 days following surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Jul 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionsStudies 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
- Patients to be included in the study will be assigned to experiment-1 or experiment-2 groups by simple randomisation. Routine treatment and care processes in the clinic will be continued for both groups of patients. Experiment 1 group patients will be showered with 4% chlorhexidine gluconate once on the preoperative night. In the experimental group 2 patients, they will be provided to take a shower with 4% chlorhexidine gluconate twice, once on the preoperative night and once on the morning of the operation, by rubbing the waist area for 10 minutes. the effect of the intervention will be evaluated in the postoperative period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Araz ASKEROĞLU, Çanakkale Onsekiz Mart University
- Investigators
- araz askeroğlu, Study director, çanakkale on sekiz mart university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801275
- Sponsor's protocol ID
- 20240703591
- Other IDs
- 2024-116
- Acronym
- SSI
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sway A, Solomkin JS, Pittet D, Kilpatrick C. Methodology and Background for the World Health Organization Global Guidelines on the Prevention of Surgical Site Infection. Surg Infect (Larchmt). 2018 Jan;19(1):33-39. doi: 10.1089/sur.2017.076. Epub 2017 May 4.
PubMed 28472604Young H, Bliss R, Carey JC, Price CS. Beyond core measures: identifying modifiable risk factors for prevention of surgical site infection after elective total abdominal hysterectomy. Surg Infect (Larchmt). 2011 Dec;12(6):491-6. doi: 10.1089/sur.2010.103. Epub 2011 Dec 5.
PubMed 22142313McClelland S 3rd, Hall WA. Postoperative central nervous system infection: incidence and associated factors in 2111 neurosurgical procedures. Clin Infect Dis. 2007 Jul 1;45(1):55-9. doi: 10.1086/518580. Epub 2007 May 21.
PubMed 17554701Abode-Iyamah KO, Chiang HY, Winslow N, Park B, Zanaty M, Dlouhy BJ, Flouty OE, Rasmussen ZD, Herwaldt LA, Greenlee JD. Risk factors for surgical site infections and assessment of vancomycin powder as a preventive measure in patients undergoing first-time cranioplasty. J Neurosurg. 2018 Apr;128(4):1241-1249. doi: 10.3171/2016.12.JNS161967. Epub 2017 May 12.
PubMed 28498056Aldrich A, Kuss MA, Duan B, Kielian T. 3D Bioprinted Scaffolds Containing Viable Macrophages and Antibiotics Promote Clearance of Staphylococcus aureus Craniotomy-Associated Biofilm Infection. ACS Appl Mater Interfaces. 2019 Apr 3;11(13):12298-12307. doi: 10.1021/acsami.9b00264. Epub 2019 Mar 21.
PubMed 30855125AORN. (2014). Preoperative Standards and Recommended Practices. Denver, CO: AORN, pp. 445-463.
Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
PubMed 28467526Damkliang J, Considine J, Kent B, Street M. Nurses' perceptions of using an evidence-based care bundle for initial emergency nursing management of patients with severe traumatic brain injury: A qualitative study. Int Emerg Nurs. 2015 Oct;23(4):299-305. doi: 10.1016/j.ienj.2015.04.004. Epub 2015 Jun 3.
PubMed 26049810Edmiston CE Jr, Leaper D. Should preoperative showering or cleansing with chlorhexidine gluconate (CHG) be part of the surgical care bundle to prevent surgical site infection? J Infect Prev. 2017 Nov;18(6):311-314. doi: 10.1177/1757177417714873. Epub 2017 Jul 26.
PubMed 29344102Liu H, Dong X, Yin Y, Chen Z, Zhang J. Reduction of Surgical Site Infections After Cranioplasty With Perioperative Bundle. J Craniofac Surg. 2017 Sep;28(6):1408-1412. doi: 10.1097/SCS.0000000000003650.
PubMed 28692506
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Number of Showers With 4% Chlorhexidine Gluconate Before Lumbar Disc Herniation Surgery on Prevention of Postoperative Surgical Site Infections: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06801275
- Acronym / sponsor ID
- SSI / 20240703591
- Conditions
- Surgical Site Infections, Lumbar Disc Herniation
- Keywords
- surgical site infections, 4% Chlorhexidine Gluconate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 30 Jan 2025 (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 (SSIs) are the most common type of nosocomial infection in surgical departments.
Although lumbar disc herniation (LDH), which is one of the common cases in neurosurgery, is a serious problem affecting postoperative SSI, morbidity and mortality, there are not enough studies on its prevention in the literature.
In the literature, there are studies on showering with chlorhexidine or other antiseptic solutions in the preoperative period to prevent SSI, but there is no study on whether the number of showers performed in the preoperative period is effective on SSI.
In this study, the effect of showering with 4% chlorhexidine gluconate before lumbar disc herniation surgery on postoperative surgical site infections will be examined. It is aimed to compare the effect of douching with 4% Chlorhexidine Gluconate before lumbar disc hernia surgery on surgical site infections. Since there are not enough studies in the literature, this study is an innovative study. In this study, it is thought that washing the surgical site with antiseptic soap containing 4% Chlorhexidine Gluconate before LDH surgery will have an effect on surgical site infections.
Detailed description
Lumbar disc herniation surgery is performed in two ways: open discectomy and microdiscectomy. In open discectomy, the skin incision is made large enough to expose the lamina and to create an area where the retractor can work with the naked eye. After the lamina is exposed, the correct distance is determined by feeling the sacrum with the fingers. Scopy assistance may be required in suspicious cases. Bone tissue is removed from the lamina to the beginning of the ligamentum flavum without damaging the facet joints. Then the ligament is removed and discectomy is performed by pushing the dura and nerve root inwards. In microdiscectomy, a smaller incision (1.5-2 cm) is made. Special retractors or tubes are inserted. Partial hemilaminotomy and discectomy are performed using microscope and microsurgical instruments.
Although the incidence of SSI after LDH surgery is not known with certainty, patients usually have various potential risk factors for CAI such as advanced age, malnutrition due to loss of appetite, and steroid use. All surgical patients are at risk for developing SSI. For patients, SSI can cause pain and discomfort, financial losses, and impaired quality of life. These infections can lead from a simple incision site abscess with purulent discharge to a complex infection that can contribute to a life-threatening condition and possible morbidity. Therefore, accurate monitoring of SSI and confirmation of the diagnosis of SSI are very important and vital for patients.
The main causative microorganisms of SSI in the preoperative period are gram-positive cocci, which are common bacterial colonies of the skin. Therefore, although WHO recommends showering with normal or antiseptic soap before surgical intervention, it is thought that the use of antiseptic soap will be more effective to destroy a larger number of skin pathogens both before and during surgical intervention.. For this reason, it was deemed appropriate to wash the surgical areas of the patients with antiseptic soap containing 4% chlorhexidine gluconate before surgery.
In the literature, there are studies showing that many factors related to the perioperative process and surgical procedure increase the risk of developing SSI. Among these, there are studies showing that bathing with an antimicrobial agent before surgical intervention reduces the overall bacterial load in the skin's own flora, thus reducing the risk of SSI.
Although there are evidence-based recommendations and some improved care practices to prevent SSI in the literatüre, there is no standardised practice with proven efficacy today. This study is a randomised controlled experimental design and requires a team approach consisting of physicians and nurses in line with the existing evidence recommendations. Therefore, it is thought that showering the operation area with antiseptic soap containing 4% Chlorhexidine Gluconate before lumbar disc herniation surgery will be effective in reducing SSI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients to be included in the study will be assigned to experiment-1 or experiment-2 groups by simple randomisation. Routine treatment and care processes in the clinic will be continued for both groups of patients. Experiment 1 group patients will be showered with 4% chlorhexidine gluconate once on the preoperative night. In the experimental group 2 patients, they will be provided to take a shower with 4% chlorhexidine gluconate twice, once on the preoperative night and once on the morning of the operation, by rubbing the waist area for 10 minutes. the effect of the intervention will be evaluated in the postoperative period.
| Arm | Type | Receives |
|---|---|---|
| The effect of 1 shower with 4% chlorhexidine gluconate on surgical site infections | Experimental | Other: 1 shower with 4% chlorhexidine gluconatePatients will be showered with 4% chlorhexidine gluconate 1 time on the night before surgery. |
| The effect of 2 shower with 4% chlorhexidine gluconate on surgical site infections | Other | Other: 2 shower with 4% chlorhexidine gluconatepatients will be provided to shower with 4% chlorhexidine gluconate twice, the night before and the morning of the operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- to communicate verbally
Key exclusion criteria (1 listed)
- Patients with diabetes mellitus side disease, pylolidal cyst surgery, any surgical history from the lumbar region and patients who will undergo lumbar disc hernia stabilisation surgery will not be included.
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 |
|---|---|---|
| 1 shower with 4% chlorhexidine gluconateAlso: They will be provided to shower with 4% chlorhexidine gluconate once on the night before surgery.Comparison of the effect of showering once with 4% Chlorhexidine Gluconate before lumbar disc herniation surgery on surgical site infections | Other | The effect of 1 shower with 4% chlorhexidine gluconate on surgical site infections |
| 2 shower with 4% chlorhexidine gluconateAlso: showering with 4% chlorhexidine gluconate twice, the night before and the morning of surgeryComparison of the effect of showering twice with 4% Chlorhexidine Gluconate before lumbar disc herniation surgery on surgical site infections | Other | The effect of 2 shower with 4% chlorhexidine gluconate on surgical site infections |
Primary outcome
surgical site infection
Time frame: 30 days following surgical intervention
Following the surgical intervention, the surgical site will be monitored for purulent discharge, abscess or cellulitis for 30 days. The patients will be followed up by the investigator and the specialist physician in the clinic until discharge and by the investigator after discharge. In the postoperative period, purulent discharge, abscess or cellulitis that develops in the surgical site within 30 days following the surgical intervention will be defined as SSI with the approval of the specialist physician.
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 Sep 2025.
- Background: PubMed 28472604Sway A, Solomkin JS, Pittet D, Kilpatrick C. Methodology and Background for the World Health Organization Global Guidelines on the Prevention of Surgical Site Infection. Surg Infect (Larchmt). 2018 Jan;19(1):33-39. doi: 10.1089/sur.2017.076. Epub 2017 May 4.
- Background: PubMed 22142313Young H, Bliss R, Carey JC, Price CS. Beyond core measures: identifying modifiable risk factors for prevention of surgical site infection after elective total abdominal hysterectomy. Surg Infect (Larchmt). 2011 Dec;12(6):491-6. doi: 10.1089/sur.2010.103. Epub 2011 Dec 5.
- Background: PubMed 17554701McClelland S 3rd, Hall WA. Postoperative central nervous system infection: incidence and associated factors in 2111 neurosurgical procedures. Clin Infect Dis. 2007 Jul 1;45(1):55-9. doi: 10.1086/518580. Epub 2007 May 21.
- Background: PubMed 28498056Abode-Iyamah KO, Chiang HY, Winslow N, Park B, Zanaty M, Dlouhy BJ, Flouty OE, Rasmussen ZD, Herwaldt LA, Greenlee JD. Risk factors for surgical site infections and assessment of vancomycin powder as a preventive measure in patients undergoing first-time cranioplasty. J Neurosurg. 2018 Apr;128(4):1241-1249. doi: 10.3171/2016.12.JNS161967. Epub 2017 May 12.
- Background: PubMed 30855125Aldrich A, Kuss MA, Duan B, Kielian T. 3D Bioprinted Scaffolds Containing Viable Macrophages and Antibiotics Promote Clearance of Staphylococcus aureus Craniotomy-Associated Biofilm Infection. ACS Appl Mater Interfaces. 2019 Apr 3;11(13):12298-12307. doi: 10.1021/acsami.9b00264. Epub 2019 Mar 21.
- BackgroundAORN. (2014). Preoperative Standards and Recommended Practices. Denver, CO: AORN, pp. 445-463.
- Background: PubMed 28467526Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.
- Background: PubMed 26049810Damkliang J, Considine J, Kent B, Street M. Nurses' perceptions of using an evidence-based care bundle for initial emergency nursing management of patients with severe traumatic brain injury: A qualitative study. Int Emerg Nurs. 2015 Oct;23(4):299-305. doi: 10.1016/j.ienj.2015.04.004. Epub 2015 Jun 3.
- Background: PubMed 29344102Edmiston CE Jr, Leaper D. Should preoperative showering or cleansing with chlorhexidine gluconate (CHG) be part of the surgical care bundle to prevent surgical site infection? J Infect Prev. 2017 Nov;18(6):311-314. doi: 10.1177/1757177417714873. Epub 2017 Jul 26.
- Background: PubMed 28692506Liu H, Dong X, Yin Y, Chen Z, Zhang J. Reduction of Surgical Site Infections After Cranioplasty With Perioperative Bundle. J Craniofac Surg. 2017 Sep;28(6):1408-1412. doi: 10.1097/SCS.0000000000003650.
- 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.
araz askeroğlu study director
çanakkale on sekiz mart university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 shower with 4% chlorhexidine gluconate and 2 shower with 4% chlorhexidine gluconate in people with Surgical Site Infections and Lumbar Disc Herniation, run by Çanakkale Onsekiz Mart University at 2 sites in Turkey (Türkiye).
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
surgical site infection (time frame: 30 days following surgical intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06801275, which also lists 10 linked publications.
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 Sep 2025.