Ankle FracturesNCT04379791
Factors Influencing the Risk of Surgical Site Infections and Wound Complications in Operatively Treated Ankle Fractures in the Elderly
An observational study of Ankle Fractures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to analyse risk factors for wound complications or surgical site infections and to analyse whether risk factors for wound complications or surgical site infections are also factors for other complications. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Data collection from routine medical records
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Mar 2020to 31 Oct 2021
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ankle fractures surgically treated at the University Hospital Basel starting with the patients operated in 2017 and then going backwards in time, until 120 patients with a surgical site infection or a wound complication are found. Then randomly collection of 120 controls among the remaining investigated patients .
Who may be able to join
- Patients ≥ 50 years with ankle fractures surgically treated at the University Hospital Basel
- Sufficient Follow up at the University Hospital Basel in order to judge wound healing complications over a 4 weeks period and fracture related infection over a 3 months period
Who cannot join
- Existence of a documented dissent.
- Distal tibia fractures and Pilon fractures
- Followed up at another institution or with no follow up at our institution for any other reason
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Orthopedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
Official title: Factors Influencing the Risk of Surgical Site Infections and Wound Complications in Operatively Treated Ankle Fractures in the Elderly - a Case Control Study
This study is to analyse risk factors for wound complications or surgical site infections and to analyse whether risk factors for wound complications or surgical site infections are also factors for other complications. Based on the data from this study it will be investigated whether a risk score can be build up to predict individual risk for a complication after surgery.
- Conditions
- Ankle Fractures
- Being tested
- Data collection from routine medical records
- Keywords
- surgical site infections, wound complications, operatively treated ankle fractures, delayed wound healing
- Medical subject headings
- Ankle Fractures, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection from routine medical recordsOther
Data collection from routine medical records for criteria for fracture related infections (FRI) and for wound complications. Data collection from routine medical records for risk factors.
| Study group | Role | What they receive |
|---|---|---|
| case cohort | Patients with a surgical site infection or a wound complication after surgical treatment of an ankle fracture. The time horizon for wound complication was set to maximally 4 weeks after surgery. Receives: Other: Data collection from routine medical records | |
| control cohort | Patients without a surgical site infection or a wound complication (normal wound-healing and suture or staple removal) after surgical treatment of an ankle fracture. Receives: Other: Data collection from routine medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
association between single risk factors and outcome (wound healing complication, surgical site infection)
In a first step analyses of the association between single risk factors and outcomes will be made. Odds ratios will be reported together with confidence intervals and p-values. In a second step it will be analyzed whether risk factors can be combined into a risk score using Tibshirani's Lasso.
Measured: at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start16 Mar 2020
- Primary completion30 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik Eckardt, PD Dr. med., Principal investigator, Dep. of Orthopedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379791
- Sponsor's protocol ID
- 2020-00318; ch20Eckardt
- Status last verified
- Dec 2021
- First submitted
- 6 May 2020
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing the Risk of Surgical Site Infections and Wound Complications in Operatively Treated Ankle Fractures in the Elderly - a Case Control Study
- ClinicalTrials.gov ID
- NCT04379791
- Acronym / sponsor ID
- 2020-00318; ch20Eckardt
- Conditions
- Ankle Fractures
- Keywords
- surgical site infections, wound complications, operatively treated ankle fractures, delayed wound healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 7 May 2020 (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.
This study is to analyse risk factors for wound complications or surgical site infections and to analyse whether risk factors for wound complications or surgical site infections are also factors for other complications. Based on the data from this study it will be investigated whether a risk score can be build up to predict individual risk for a complication after surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case cohort | – | Other: Data collection from routine medical recordsPatients with a surgical site infection or a wound complication after surgical treatment of an ankle fracture. The time horizon for wound complication was set to maximally 4 weeks after surgery. |
| control cohort | – | Other: Data collection from routine medical recordsPatients without a surgical site infection or a wound complication (normal wound-healing and suture or staple removal) after surgical treatment of an ankle fracture. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ankle fractures surgically treated at the University Hospital Basel starting with the patients operated in 2017 and then going backwards in time, until 120 patients with a surgical site infection or a wound complication are found. Then randomly collection of 120 controls among the remaining investigated patients .
Key inclusion criteria (2 listed)
- Patients ≥ 50 years with ankle fractures surgically treated at the University Hospital Basel
- Sufficient Follow up at the University Hospital Basel in order to judge wound healing complications over a 4 weeks period and fracture related infection over a 3 months period
Key exclusion criteria (3 listed)
- Existence of a documented dissent.
- Distal tibia fractures and Pilon fractures
- Followed up at another institution or with no follow up at our institution for any other reason
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 |
|---|---|---|
| Data collection from routine medical recordsData collection from routine medical records for criteria for fracture related infections (FRI) and for wound complications. Data collection from routine medical records for risk factors. | Other | case cohort, control cohort |
Primary outcome
association between single risk factors and outcome (wound healing complication, surgical site infection)
Time frame: at Baseline
In a first step analyses of the association between single risk factors and outcomes will be made. Odds ratios will be reported together with confidence intervals and p-values. In a second step it will be analyzed whether risk factors can be combined into a risk score using Tibshirani's Lasso.
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 13 Dec 2021.
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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.
Henrik Eckardt, PD Dr. med. principal investigator
Dep. of Orthopedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fractures, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
association between single risk factors and outcome (wound healing complication, surgical site infection) (time frame: at Baseline). 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 13 Dec 2021.