Re_FRI: Long--term Outcome Analysis of Fracture--related Infections

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT04455217
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Actual Duration (Months): 12.5
• Patients Per Site Per Month: 28

Study Details

Study Description

Brief Summary

This retrospective analysis of medical records is to identify risk factors for treatment failures in fracture-associated infections (FAI) at the University Hospital Basel.

Condition or Disease	Intervention/Treatment	Phase
Fracture-associated Infection (FAI)	Other: data collection from patients with FAI (occuring January 2000 until December 2019)

Study Design

• Study Type: Observational
• Actual Enrollment: 350 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Long--term Outcome Analysis of Fracture--related Infections (Re_FRI)
• Actual Study Start Date: Feb 13, 2020
• Actual Primary Completion Date: Feb 28, 2021
• Actual Study Completion Date: Feb 28, 2021

Outcome Measures

Primary Outcome Measures

1. number of flap failures at discharge from hospital [at baseline]

   number of flap failures at discharge from hospital

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with FAI

Exclusion Criteria:

• documented denial of consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie	Basel		Switzerland	4031

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Dirk Johannes Schaefer, Prof. Dr. med., Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie; University Hospital Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT04455217
• Other Study ID Numbers: 2020-00214; ch20Schaefer
• First Posted: Jul 2, 2020
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: prosthesis infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Fractures, Bone

Study Results

No Results Posted as of Aug 25, 2021