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

NCT04379791 | Completed

• 1 other identifier: 2020-00318; ch20Eckardt
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures

Keywords

surgical site infections; wound complications; operatively treated ankle fractures; delayed wound healing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Data collection from routine medical records OTHER

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.

case cohort; control cohort

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Dep. of Orthopedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Ankle Fractures; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Eckardt, PD Dr. med.

  Dep. of Orthopedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 7, 2020
• Study Start: March 16, 2020
• Primary Completion: October 30, 2021
• Study Completion: October 31, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

CH (1)