NCT03686553

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;

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

2.9 years

First QC Date

September 25, 2018

Last Update Submit

September 26, 2018

Conditions

Surgical Site Infections

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

infected, with SSI

patients with SSI

Other: laboratory-based data collection

non-infected

patients without SSI

Other: laboratory-based data collection

Interventions

laboratory-based data collectionOTHER

laboratory-based surveillance of SSI

infected, with SSInon-infected

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 27, 2018

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 28, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share