Surgical Site Infection
Conditions
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 Prevention Bundle. D
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 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).
Interventions
BEHAVIORALImplementation of the AO Trauma SSI Prevention Bundle
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
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Masking description
It is that preventino measures are enforced in the hospital. This will apply to all patients and no masking is required.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* • 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection Rate | within 3 months after surgery | Surgical site infection rate as defined by CDC or FRI definition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implementation success of the AOT SSI Prevention Bundle | up to 48 months | Compliance rate for each measure of the bundle before and after the intervention |
| Evaluation of attitudes, perception and knowledge concerning SSI | up to 48 months | Cross sectional survey of surgeons at participating sites performed before and after the implementation of the AOT SSI Prevention Bundle |
| Surgeon satisfaction | up to 48 months | 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 |
| Health-economic analysis | up to 48 months | 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.). |
Countries
Argentina, Germany, Romania, South Korea, Spain, United States
Outcome results
None listed