Surgical Site InfectionNCT04285697
Infection Prevention Bundle in Brain Tumor Surgery
A study testing infection prevention bundle in people with Surgical Site Infection and Brain Tumor, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effectiveness of an infection prevention bundle on surgical site infections in patients undergone brain tumor surgery. The patients were divided into 2 groups: infection prevention bundle group and control group Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Brain Tumor
- What is being tested?
- infection prevention bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2020to 3 Dec 2022
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with American Society of Anesthesiologists score I-II-III
- Surgical intervention planned with the diagnosis of brain tumor
- No systemic infection such as sepsis, pneumonia, blood infections, or intracranial infection such as meningitis, abscess or local infection.
- Not having a mental illness
Who cannot join
- Being morbidly obese (BMI> 40kg / m2)
- Immune deficiency
- Using immunosuppressive drugs
- Being addicted to alcohol and substances
- Having received radiotherapy and / or chemotherapy before surgery
- Having the disease that requires infective endocarditis prophylaxis (Rheumatic valve diseases, prosthetic heart valves, previous endocarditis, etc.)
Show all 11Show fewer
- Corruption of cranium integrity and emergency surgery planned
- Having systemic or intracranial infections
- Transfenoidal surgery intervention planned
- Using implants during surgical intervention
- Using external ventricular drainage / lumbar drainage during and after surgical intervention
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Neurosurgery, Bakirkoy Research and Training Hospital for Neurology, Neurosurgery, and Psychiatry, İstanbul, Turkey
Istanbul
About this study
Official title: The Impact of An Infection Prevention Bundle on Surgical Site Infections in Brain Tumor Surgery
This study aimed to evaluate the effectiveness of an infection prevention bundle on surgical site infections in patients undergone brain tumor surgery. The patients were divided into 2 groups: infection prevention bundle group and control group
Read the detailed description
In cranial neurosurgery, surgical site infections (SSIs) occur in 0.5%-7.2% of patients, frequently require reoperations and long-lasting antibiotic treatment, and are often life threatening.
Patients with malignant brain tumors often harbor several potential risk factors for SSI such as advanced age, poor nutritional state owing to appetite loss, poor sanitary condition of the head skin due to low performance status, immunosuppression caused by steroid or chemotherapeutic agents, and surgical site skin problems caused by post-operative irradiation. Therefore, patients with malignant brain tumors theoretically are a high-risk group for SSI.
A care bundle technique, which is an aggregate of evidence-based practices expected to improve patient outcomes, has been introduced to reduce the incidence of SSI.
The infection prevention bundle (IPB) implemented items:
- Preoperative counseling and questionnaire: patient counseling and preparation instructions, screening questions for signs of infection, and presence of open or nonhealing wounds.
- Nasal methicillin-resistant and methicillin-sensitive Staphylococcus aureus decolonization: preoperative 24 hours ago twice-daily application of 2% mupirocin ointment to bilateral nares with final application on the morning of surgery.
- Body decolonization: Cleansing with 4% chlorhexidine gluconate shower the evening before surgery and the morning of surgery.
- Preoperative weight-based antibiotics within 60 minutes of incision
- Strict draping and surgical techniques the standardization
- Irrigation of the surgical site with warm Isotonic NaCl solution before skin closure
- Postoperative wound care education to patient and family
Care bundle in preventing surgical site infections is an approach that requires team-based service delivery and physician-nurse cooperation. Although it is known abroad and use of existing care bundle is not a new concept in Turkey, much is unknown, it is determined that widespread and effective use. Experimental studies on the care bundles are needed especially in our country to prevent surgical site infections.
- Conditions
- Surgical Site Infection, Brain Tumor
- Being tested
- infection prevention bundle
- Keywords
- Care Bundles,, Surgical Wound Infection,, craniyal surgery, nursing care
- Medical subject headings
- Surgical Wound Infection, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infection prevention bundleOther
The infection prevention bundle (IPB) implemented items:
Preoperative counseling and questionnaire: patient counseling and preparation instructions, screening questions for signs of infection, and presence of open or nonhealing wounds.
Nasal methicillin-resistant and methicillin-sensitive Staphylococcus aureus decolonization: preoperative 24 hours ago twice-daily application of 2% mupirocin ointment to bilateral nares with final application on the morning of surgery.
Body decolonization: Cleansing with 4% chlorhexidine gluconate shower the evening before surgery and the morning of surgery.
Preoperative weight-based antibiotics within 60 minutes of incision
Strict draping and surgical techniques the standardization Irrigation of the surgical site with warm Isotonic NaCl solution before skin closure Postoperative wound care education to patient and family
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | During the outpatient clinic visit, an information leaflet will be given about the subjects that should be considered for prevention of SSI before surgery. 2% mupirocin ointment will be applied to the nostrils with the swab twice-daily before surgery and once on the morning of surgery. Body cleaning will be done with 4% chlorhexidine gluconate shower the night before the surgery. Prophylactic antibiotics by weight will be administered within 60 minutes of anesthesia induction. The planned aseptic technique will be applied and a strict draping will be used in the incision site. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 1 hour during the operation and data will be recorded on the data collection form. Before the skin closes, the surgical site will be washed with warm Isotonic NaCl solution. Wound care education will be provided to the patient and family before discharge. Receives: Other: infection prevention bundle |
| group 2 control | No intervention | The pre-operative service sociodemographic characteristics form, preoperative, intra and postoperative evaluation forms will be completed. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 1 hour during the operation and data will be recorded on the data collection form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection Rate
Within the postoperative 90 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed.
Patient's case doctor will be responsible to document in date collection form, if there are surgical site infection occur. A research team is responsible for the data collection. The definition of surgical site infection will be according to CDC definitions of nosocomial surgical site infections: a modification of CDC definitions of surgical wound infection.
Measured: Postoperative 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start20 Feb 2020
- Primary completion3 Oct 2022 (estimated)
- Study completion3 Dec 2022 (estimated)
Why it stopped: Due to the COVID-19 pandemic, elevtive sugeries were temproraily delayed in our country. It's targeted to take cases again as of August 2020
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
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Balci, Istanbul University - Cerrahpasa
- Investigators
- Ayfer Özbaş, Professor, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285697
- Sponsor's protocol ID
- IstanbulUC
- Status last verified
- Aug 2022
- First submitted
- 25 Feb 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of An Infection Prevention Bundle on Surgical Site Infections in Brain Tumor Surgery
- ClinicalTrials.gov ID
- NCT04285697
- Acronym / sponsor ID
- IstanbulUC
- Conditions
- Surgical Site Infection, Brain Tumor
- Keywords
- Care Bundles,, Surgical Wound Infection,, craniyal surgery, nursing care
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to the COVID-19 pandemic, elevtive sugeries were temproraily delayed in our country. It's targeted to take cases again as of August 2020
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 3 Oct 2022 (estimated)
- Study completion
- 3 Dec 2022 (estimated)
- First posted
- 26 Feb 2020 (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.
This study aimed to evaluate the effectiveness of an infection prevention bundle on surgical site infections in patients undergone brain tumor surgery. The patients were divided into 2 groups: infection prevention bundle group and control group
Detailed description
In cranial neurosurgery, surgical site infections (SSIs) occur in 0.5%-7.2% of patients, frequently require reoperations and long-lasting antibiotic treatment, and are often life threatening.
Patients with malignant brain tumors often harbor several potential risk factors for SSI such as advanced age, poor nutritional state owing to appetite loss, poor sanitary condition of the head skin due to low performance status, immunosuppression caused by steroid or chemotherapeutic agents, and surgical site skin problems caused by post-operative irradiation. Therefore, patients with malignant brain tumors theoretically are a high-risk group for SSI.
A care bundle technique, which is an aggregate of evidence-based practices expected to improve patient outcomes, has been introduced to reduce the incidence of SSI.
The infection prevention bundle (IPB) implemented items:
- Preoperative counseling and questionnaire: patient counseling and preparation instructions, screening questions for signs of infection, and presence of open or nonhealing wounds.
- Nasal methicillin-resistant and methicillin-sensitive Staphylococcus aureus decolonization: preoperative 24 hours ago twice-daily application of 2% mupirocin ointment to bilateral nares with final application on the morning of surgery.
- Body decolonization: Cleansing with 4% chlorhexidine gluconate shower the evening before surgery and the morning of surgery.
- Preoperative weight-based antibiotics within 60 minutes of incision
- Strict draping and surgical techniques the standardization
- Irrigation of the surgical site with warm Isotonic NaCl solution before skin closure
- Postoperative wound care education to patient and family
Care bundle in preventing surgical site infections is an approach that requires team-based service delivery and physician-nurse cooperation. Although it is known abroad and use of existing care bundle is not a new concept in Turkey, much is unknown, it is determined that widespread and effective use. Experimental studies on the care bundles are needed especially in our country to prevent surgical site infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: infection prevention bundleDuring the outpatient clinic visit, an information leaflet will be given about the subjects that should be considered for prevention of SSI before surgery. 2% mupirocin ointment will be applied to the nostrils with the swab twice-daily before surgery and once on the morning of surgery. Body cleaning will be done with 4% chlorhexidine gluconate shower the night before the surgery. Prophylactic antibiotics by weight will be administered within 60 minutes of anesthesia induction. The planned aseptic technique will be applied and a strict draping will be used in the incision site. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 1 hour during the operation and data will be recorded on the data collection form. Before the skin closes, the surgical site will be washed with warm Isotonic NaCl solution. Wound care education will be provided to the patient and family before discharge. |
| group 2 control | No intervention | –The pre-operative service sociodemographic characteristics form, preoperative, intra and postoperative evaluation forms will be completed. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 1 hour during the operation and data will be recorded on the data collection form. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with American Society of Anesthesiologists score I-II-III
- Surgical intervention planned with the diagnosis of brain tumor
- No systemic infection such as sepsis, pneumonia, blood infections, or intracranial infection such as meningitis, abscess or local infection.
- Not having a mental illness
Key exclusion criteria (11 listed)
- Being morbidly obese (BMI> 40kg / m2)
- Immune deficiency
- Using immunosuppressive drugs
- Being addicted to alcohol and substances
- Having received radiotherapy and / or chemotherapy before surgery
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 |
|---|---|---|
| infection prevention bundleThe infection prevention bundle (IPB) implemented items: Preoperative counseling and questionnaire: patient counseling and preparation instructions, screening questions for signs of infection, and presence of open or nonhealing wounds. Nasal methicillin-resistant and methicillin-sensitive Staphylococcus aureus decolonization: preoperative 24 hours ago twice-daily application of 2% mupirocin ointment to bilateral nares with final application on the morning of surgery. Body decolonization: Cleansing with 4% chlorhexidine gluconate shower the evening before surgery and the morning of surgery. Preoperative weight-based antibiotics within 60 minutes of incision Strict draping and surgical techniques the standardization Irrigation of the surgical site with warm Isotonic NaCl solution before skin closure Postoperative wound care education to patient and family | Other | group 1 |
Primary outcome
Surgical Site Infection Rate
Time frame: Postoperative 90 days
Within the postoperative 90 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. Patient's case doctor will be responsible to document in date collection form, if there are surgical site infection occur. A research team is responsible for the data collection. The definition of surgical site infection will be according to CDC definitions of nosocomial surgical site infections: a modification of CDC definitions of surgical wound infection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Surgical Site Infection
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruiting
Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
Surgical Site Infection, Skin Cancer
Active, not recruiting
Effectiveness of Digital Game-Based Learning in Teaching Surgical Site Infection Prevention to Nursing Students
Surgical Site Infection Prevention, Nursing Education
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.
Ayfer Özbaş, Professor study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infection prevention bundle in people with Surgical Site Infection and Brain Tumor, run by Istanbul University - Cerrahpasa at 1 site 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 4 inclusion and 11 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: paused, as of the sponsor's last update on 4 Aug 2022. 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 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?
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?
Surgical Site Infection Rate (time frame: Postoperative 90 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 4 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.