St. Barbara Specialised Regional Hospital No. 5: Surveill... | NCT03686553

Studies
St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections

NCT03686553

Sponsor

Polskie Towarzystwo Zakażeń Szpitalnych

Status

Completed

Last Update Posted

Sep 28, 2018Actual

Enrollment

5,239Actual

Phase

Not provided

Conditions

Surgical Site Infections

Interventions

laboratory-based data collection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 25, 2018

First Submission Date that Met QC Criteria

Sep 25, 2018

First Posted Date

Sep 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2018

Last Update Posted Date

Sep 28, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrospective laboratory-based data collection study of surgical site infections: Surveillance of Healthcare-Associated Infections in Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland;

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,239Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
infected, with SSI		patients with SSI	Other: laboratory-based data collection
non-infected		patients without SSI	Other: laboratory-based data collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laboratory-based data collection	Other	laboratory-based surveillance of SSI	infected, with SSI non-infected

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgical site infection incidence rate	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	The follow-up period was 30 days for the superficial SSI's, and 90 days for deep or organ/space infections following arthroplasties

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient being treated in the Department and Clinic of Orthopaedic and Trauma Surgery, St. Barbara Specialised Regional Hospital No. 5, Sosnowiec
patients undergoing surgery in studied unit

Exclusion Criteria:

under 18 years of age
surgery of a different type than orthopedics
non-surgical treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients undergoing surgery in the Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided