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
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 year, the bundle will be implemented and data on 4,238 additional patients will be collected. The incidence rate on surgical site infection before and after the intervention will be compared. We hypothesize that this intervention will reduce the infection rate within the first 3 months after surgery from 6% to 4.5% (5% to 3.75% in closed fractures and from 10% to 7.5% in open fractures).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
222
AOT SSI Prevention Bundle Preventive measure 1. Antibiotic prophylaxis 2. Perioperative antibiotics 3. Oxygen administration 4. Patient temperature 5. Surgeon protective wear 6. Patient operative skin preparation 7. Suction drains 8. Blood glucose level 9. Red cell transfusion 10. Dressing changes
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
Infection Rate
Surgical site infection rate as defined by CDC or FRI definition
Time frame: within 3 months after surgery
Implementation success of the AOT SSI Prevention Bundle
Compliance rate for each measure of the bundle before and after the intervention
Time frame: up to 48 months
Evaluation of attitudes, perception and knowledge concerning SSI
Cross sectional survey of surgeons at participating sites performed before and after the implementation of the AOT SSI Prevention Bundle
Time frame: up to 48 months
Surgeon satisfaction
Cross sectional survey of opinion concerning user friendliness of the AOT SSI Prevention Bundle, value of the educational intervention and intention to adopt the AOT SSI Prevention Bundle long term before and after its implementation
Time frame: up to 48 months
Health-economic analysis
The clinical effectiveness of the implementation of the AOT SSI Prevention Bundle and consecutively the costs saved by preventing infections and its treatment is compared against the costs which have to be invested in order to implement the AOT SSI Prevention Bundle (e.g. costs generated by development of teaching material, time needed to teach/implement the intervention, extra material needed according to the interventions etc.).
Time frame: up to 48 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 4 more locations