Surgical Site InfectionsNCT03686553
St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections
An observational study of Surgical Site Infections, run by Polskie Towarzystwo Zakażeń Szpitalnych.
Trial 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; Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgical Site Infections
- What is being tested?
- laboratory-based data collection
- How many people
- 5,239 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing surgery in the Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland
Who may be able to join
- 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
Who cannot join
- under 18 years of age
- surgery of a different type than orthopedics
- non-surgical treatment
About this study
Retrospective laboratory-based data collection study of surgical site infections: Surveillance of Healthcare-Associated Infections in Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland;
- Conditions
- Surgical Site Infections
- Being tested
- laboratory-based data collection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory-based data collectionOther
laboratory-based surveillance of SSI
| Study group | Role | What they receive |
|---|---|---|
| infected, with SSI | patients with SSI Receives: Other: laboratory-based data collection | |
| non-infected | patients without SSI Receives: Other: laboratory-based data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The follow-up period was 30 days for the superficial SSI's, and 90 days for deep or organ/space infections following arthroplasties
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polskie Towarzystwo Zakażeń Szpitalnych
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686553
- Sponsor's protocol ID
- PTZS
- Status last verified
- Sep 2018
- First submitted
- 25 Sep 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections
- ClinicalTrials.gov ID
- NCT03686553
- Acronym / sponsor ID
- PTZS
- Conditions
- Surgical Site Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,239 participants (actual)
- Lead sponsor
- Polskie Towarzystwo Zakażeń SzpitalnychUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective laboratory-based data collection study of surgical site infections: Surveillance of Healthcare-Associated Infections in Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland;
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infected, with SSI | – | Other: laboratory-based data collectionpatients with SSI |
| non-infected | – | Other: laboratory-based data collectionpatients without SSI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing surgery in the Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- under 18 years of age
- surgery of a different type than orthopedics
- non-surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory-based data collectionlaboratory-based surveillance of SSI | Other | infected, with SSI, non-infected |
Primary outcome
surgical site infection incidence rate
Time frame: The follow-up period was 30 days for the superficial SSI's, and 90 days for deep or organ/space infections following arthroplasties
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Surgical Site Infections
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infections, run by Polskie Towarzystwo Zakażeń Szpitalnych.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical site infection incidence rate (time frame: The follow-up period was 30 days for the superficial SSI's, and 90 days for deep or organ/space infections following arthroplasties). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.