Factors Influencing the Risk of Surgical Site Infections and Wound Complications in Operatively Treated Ankle Fractures in the Elderly

December 10, 2021 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Dep. of Orthopedics and Traumatology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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 .

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Data collection from routine medical records
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.
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.
Other: Data collection from routine medical records
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Henrik Eckardt, PD Dr. med., Dep. of Orthopedics and Traumatology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2020

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 13, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00318; ch20Eckardt

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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