Infection Prevention Bundle in Brain Tumor Surgery

NCT04285697 | Suspended DMC

• 1 other identifier: IstanbulUC
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Site Infection; Brain Tumor

Keywords

Care Bundles,; Surgical Wound Infection,; craniyal surgery; nursing care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

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.

Interventions

infection prevention bundle OTHER

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

group 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical Wound Infection; Brain Neoplasms

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ayfer Özbaş, Professor

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 26, 2020
• Study Start: February 20, 2020
• Primary Completion: October 3, 2022
• Study Completion: December 3, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

TU (1)