Surgical and Non-surgical Infections of Neurosurgical Patient: Before-after Cohort Study

NCT03759652 | Completed

• 1 other identifier: PTZS Neurosurgery 2018
• Study Type: observational
• Target: 10,332
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous surveillance in 2003-2017 allowed to detect HAIs in patients staying in a 42-bed neurosurgery unit with 6 intensive neurosurgical supervision beds. 10,332 surgical patients were qualified for the study. The study was carried out in the framework of a national surveillance of HAI programme following methodology recommended by Healthcare-Associated Infections Surveillance Network (HAI-Net), European Centre for Disease Prevention and Control. Intervention in this before-after study (2003-2017) comprised standardised surveillance of HAI with regular analysis and feedback.

Conditions

Neurosurgery

Keywords

neurosurgery; surgical site infections; spinal surgery; craniotomy; laminectomy

Outcome Measures

Primary Outcomes (3)

• incidence of surgical site infection

  the cumulative incidence of surgical site infection (SSI) was calculated by dividing the number of SSI cases by the number of patients undergoing surgery and multiplying by 100

  2003-2017

• incidence of pneumonia

  the cumulative incidence of post-procedure pneumonia was calculated by dividing the number of pneumonia cases by the number of patients undergoing surgery and multiplying by 100

  2003-2017

• incidence of bloodstream infections

  the cumulative incidence of bloodstream infections (BSI) was calculated by dividing the number of BSI cases by the number of patients undergoing surgery and multiplying by 100

  2003-2017

Study Arms (2)

infected, before-after studyt: 2003

neurosurgical patients; 2003: the beggining of active and target HAI surveillance

Behavioral: before-after study

infected, before-after studyt: 2017

neurosurgical patients; 2017: the effective of active and target HAI surveillance

Behavioral: before-after study

Interventions

before-after study BEHAVIORAL

The data analysed involve the time when the targeted, active surveillance of infections was establised, initially: 2003-2017, using tools (definitions, protocols) in accordance with the National Healthcare Safety Network (NHSN), then from 2012, HAI recognition methodology and HAI record-keeping has followed the Surveillance Network (HAI-Net), European Centre for Disease Prevention and Control (ECDC).

infected, before-after studyt: 2003; infected, before-after studyt: 2017

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery in the Neurosurgery Ward in St. Luke Provincial Hospital in Tarnów, Poland, in 2003-2017

You may qualify if:

• clinical diagnosis of neurosurgical disorders
• requiring surgery

You may not qualify if:

• patients without surgery intervention

Sponsors & Collaborators

• Polskie Towarzystwo Zakażeń Szpitalnych: lead

Study Sites (1)

Jagiellonian University Medical School

Krakow, 31-121, Poland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Controlled Before-After Studies

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jadwiga Wójkowska-Mach

  Jagiellonian University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: January 1, 2003
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 3, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)