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Infection Prevention Bundle in Brain Tumor Surgery

Primary Purpose

Surgical Site Infection, Brain Tumor

Status
Suspended
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
infection prevention bundle
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Care Bundles,, Surgical Wound Infection,, craniyal surgery, nursing care

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)
  • 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

Sites / Locations

  • Department of Neurosurgery, Bakirkoy Research and Training Hospital for Neurology, Neurosurgery, and Psychiatry, İstanbul, Turkey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group 1

group 2 control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2020
Last Updated
August 2, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04285697
Brief Title
Infection Prevention Bundle in Brain Tumor Surgery
Official Title
The Impact of An Infection Prevention Bundle on Surgical Site Infections in Brain Tumor Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Suspended
Why 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
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
October 3, 2022 (Anticipated)
Study Completion Date
December 3, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection, Brain Tumor
Keywords
Care Bundles,, Surgical Wound Infection,, craniyal surgery, nursing care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
group 2 control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
infection prevention bundle
Intervention Description
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
Primary Outcome Measure Information:
Title
Surgical Site Infection Rate
Description
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.
Time Frame
Postoperative 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayfer Özbaş, Professor
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neurosurgery, Bakirkoy Research and Training Hospital for Neurology, Neurosurgery, and Psychiatry, İstanbul, Turkey
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Infection Prevention Bundle in Brain Tumor Surgery

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