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

Completed

• Conditions: Ankle Fractures

• Registration Number: NCT04379791
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-16
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-07
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
association between single risk factors and outcome (wound healing complication, surgical site infection)	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.

Trial Locations

Locations (1)

Dep. of Orthopedics and Traumatology, University Hospital Basel; 🇨🇭 Basel, Switzerland