- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759652
Surgical and Non-surgical Infections of Neurosurgical Patient: Before-after Cohort Study
Surveillance of Surgical Site Infections and Non-surgical Infections of Neurosurgical Patient. Retrospective Before-after Cohort Study at a Tertiary Care Hospital in Poland
Study Overview
Detailed Description
Supervision of HAIs was carried out in the neurosurgery unit in 2003-2017 in St. Luke Provincial Hospital in Tarnów, Poland. The department offers 42 hospital beds (including 6 intensive supervision beds, where mechanical ventilation is also used). Patients in very poor clinical condition do not stay in this department as they are generally sent to a separate general intensive care unit. Active surveillance of infections was implemented in the hospital in 2001 and the experiences concerning the neurosurgery unit were already the subject of previous general analyses not including trend analysis or detailed analyses of various HAI clinical forms [Wałaszek NCH 2015]. The Infection Control Team consists of a doctor, who is employed on a 1/3 full-time equivalent basis and 4 full-time epidemiological nurses.
The data analysed involve the time when the unit in question began targeted, active surveillance of infections, initially: 2003-2012, using tools (definitions, protocols) in accordance with the National Healthcare Safety Network (NHSN) [Emori, NNIS], 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) [ECDC 4.3, 2012; HAI-Net ICU 1.02. ECDC; 2015]. For the purposes of this analysis, HAI cases originally qualified in 2002-2012 according to the NHSN criteria were retrospectively subjected to reclassification according to the ECDC definitions from 2012 (they concerned BSI, PN and UTI), hence, all HAI cases were qualified into individual HAI categories according to the ECDC case definition keeping the division into: catheter-related BSI and BSI secondary to another infection, five subcategories of PN and three forms of SSI. The surgeries performed were stratified by type of operation conforming to the International Classification of Procedures in Medicine ICD 9-CM, according to the NHSN code (International Classification of Diseases) (Supplementarty Material, Table 1).
Beginning in 2003, changes were being implemented as regards supervision of infections by the Infection Control Team together with the staff of the departments (neurosurgery, operating block and infection control team), which encompassed, among others:
- hospital admission rules for shortening of the pre-operative stay and optimal patient preparation for surgery to limit emergency surgery; preparation of the surgical team
- work organization of the operating block: among others, preoperative checklist, surgical hand hygiene, preparation of the operating field and surgical drape, application of antiseptic to the edges of the wound before sewing it;
- perioperative procedure: patient preparation for surgery, among others, bathing the patient immediately prior to surgery, hair removal, changing the bed linen and patient's clothing immediately before surgery, patient care during the postoperative period, and above all, the 5 moments for hand hygiene and post-operative dressing and wound control.
In addition: regular analysis and feedback have also been implemented.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Kraków, Poland, 31-121
- Jagiellonian University Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- clinical diagnosis of neurosurgical disorders
- requiring surgery
Exclusion Criteria:
patients without surgery intervention
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
infected, before-after studyt: 2003
neurosurgical patients; 2003: the beggining of active and target HAI surveillance
|
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: 2017
neurosurgical patients; 2017: the effective of active and target HAI surveillance
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of surgical site infection
Time Frame: 2003-2017
|
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
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2003-2017
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incidence of pneumonia
Time Frame: 2003-2017
|
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
Time Frame: 2003-2017
|
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
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2003-2017
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Collaborators and Investigators
Investigators
- Principal Investigator: Jadwiga Wójkowska-Mach, Jagiellonian University Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTZS Neurosurgery 2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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