Clinical trial NCT04285697: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Surgical Site Infection
Brain Tumor
Keywords: Care Bundles,
Surgical Wound Infection,
craniyal surgery
nursing care
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Surgical Site Infection Rate
timeFrame: Postoperative 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Department of Neurosurgery, Bakirkoy Research and Training Hospital for Neurology, Neurosurgery, and Psychiatry, İstanbul, Turkey
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayfer Özbaş, Professor
role: STUDY_DIRECTOR
References: