Status:
TERMINATED
AO Multicenter Intervention Trial for Prevention of Surgical Site Infection
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Surgical Site Infection
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 P...
Detailed Description
During the first phase of the study, 4,238 patients will be recruited and the baseline incidence of surgical site infection at each participating site will be determined. At the beginning of the third...
Eligibility Criteria
Inclusion
- • 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
Exclusion
- 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
Key Trial Info
Start Date :
December 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT03380273
Start Date
December 6 2019
End Date
December 31 2021
Last Update
January 18 2022
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of Kentucky Healthcare
Lexington, Kentucky, United States, 40536-0284
3
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
4
Missouri Orthopaedic Institute
Columbia, Missouri, United States, 65212