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Patient enrollment too small and slow due to pandemic situation
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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.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-intervention | No Intervention | The number of SSI are collected in this phase. Patients with fractures are enrolled and their standard of care treatment is observed. | |
| post-intervention | Other | Here the same observations are made as in the first arm, however this is after the hospital staff was thought the prevention measures (all by themselves approved) and enforced to be applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation of the AO Trauma SSI Prevention Bundle | Behavioral | AOT SSI Prevention Bundle Preventive measure
|
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rate | Surgical site infection rate as defined by CDC or FRI definition | within 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation success of the AOT SSI Prevention Bundle | Compliance rate for each measure of the bundle before and after the intervention | up to 48 months |
| Evaluation of attitudes, perception and knowledge concerning SSI |
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Inclusion Criteria:
• Age > 18 years
Recent fracture (< 10 days) located in femur, tibia or humerus
Primary fracture treatment with surgery and use of any of the following:
Informed consent obtained (if required by local EC/IRB), i.e.:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Kates, MD | VCU Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| University of Kentucky Healthcare |
There is no plan to share the individual participant data. The analyses will be done based on groups and these data will be published and shared
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During two years, patients with fractures are recorded and the occurence of surgical site infections (SSI) in these patients is monitored in different sites over the world. After two years, a bundle of known prevention measures are teached and enforced in these sites. Then the occurence of SSI in fracture patients is monitored for another two years to see whether the bundle decreased the SSI occurence.
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It is that preventino measures are enforced in the hospital. This will apply to all patients and no masking is required.
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|
Cross sectional survey of surgeons at participating sites performed before and after the implementation of the AOT SSI Prevention Bundle
| 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 | 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.). | up to 48 months |
| Lexington |
| Kentucky |
| 40536-0284 |
| United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Missouri Orthopaedic Institute | Columbia | Missouri | 65212 | United States |
| Saint Louis University | St Louis | Missouri | 63110 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Virginia | Charlottesville | Virginia | 22908-0159 | United States |
| VCU Medical Center | Richmond | Virginia | 23298-0153 | 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 |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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