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

Ankle Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379791
• Other study ID #: 2020-00318; ch20Eckardt
• Status: Completed
• Start date: March 16, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 31, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Infections
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Dep. of Orthopedics and Traumatology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at Baseline