Infection Prevention Bundle in Brain Tumor Surgery

Brain Tumor Clinical Trial

Official title:

The Impact of An Infection Prevention Bundle on Surgical Site Infections in Brain Tumor Surgery

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04285697
• Other study ID #: IstanbulUC
• Status: Suspended
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: December 3, 2022

Study information

• Verified date: August 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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:

1. Preoperative counseling and questionnaire: patient counseling and preparation instructions, screening questions for signs of infection, and presence of open or nonhealing wounds.

2. 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.

3. Body decolonization: Cleansing with 4% chlorhexidine gluconate shower the evening before surgery and the morning of surgery.

4. Preoperative weight-based antibiotics within 60 minutes of incision

5. Strict draping and surgical techniques the standardization

6. Irrigation of the surgical site with warm Isotonic NaCl solution before skin closure

7. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 300
• Est. completion date: December 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• infection prevention bundle
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

Locations

Country	Name	City	State
Turkey	Department of Neurosurgery, Bakirkoy Research and Training Hospital for Neurology, Neurosurgery, and Psychiatry, Istanbul, Turkey	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Postoperative 90 days