AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

Stopped early · Not applicable

Conditions studied: Surgical Site Infection

In brief

This study is designed to collect data from 8,476 fracture patients during a pre-and post-intervention phases of two years length each. The intervention consists on the implementation of the AOT SSI Prevention Bundle. D

Key facts

Study ID

NCT03380273

Run by

AO Clinical Investigation and Publishing Documentation

People needed

222

Starts

2019-12-06

Expected to finish

2021-12-31

Last updated by the study team

2022-01-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • Age > 18 years
• Recent fracture (< 10 days) located in femur, tibia or humerus
• Any type of open or closed fracture
• Produced by high or low energy trauma
• Primary fracture treatment with surgery and use of any of the following:
• Intramedullary or extramedullary devices including cases in which a temporary external fixator is used
• Joint replacement
• Informed consent obtained (if required by local EC/IRB), i.e.:
• Ability to understand the content of the patient information/ICF
• Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
• Signed and dated EC/IRB approved written informed consent

You may not qualify if…

• Pathologic fracture secondary to tumors, infection or cysts
• Patients with an underlying chronic, bone and joint infection or prior history of a bone and joint infection
• Refracture and non-union
• Peri-implant fractures
• Patients with terminal illness
• Pregnancy or women planning to conceive within the study period
• Prisoner
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• University of Kentucky Healthcare — Lexington, Kentucky, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Missouri Orthopaedic Institute — Columbia, Missouri, United States
• Saint Louis University — St Louis, Missouri, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States
• VCU Medical Center — Richmond, Virginia, United States
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• University Hospital Gießen — Giessen, Germany
• University Hospital Regensburg — Regensburg, Germany
• Spitalul Clinic de Urgenta Floreasca — Bucharest, Romania
• Korea University Guro Hospital — Seoul, South Korea
• Hospital Universitari Parc Tauli — Sabadell, Spain

Full record on ClinicalTrials.gov

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