An interventional study of Implementation of the AO Trauma SSI Prevention Bundle in Surgical Site Infection, sponsored by AO Clinical Investigation and Publishing Documentation. Terminated at 14 sites in 6 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-01-18.
Sponsored by AO Clinical Investigation and Publishing Documentation · Not applicable, Interventional, and Prevention
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).
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's enrollment of 222 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →AO Clinical Investigation and Publishing Documentation is the lead sponsor of 50 studies on the registry; none are open to participants now.
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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:
obtained (if required by local EC/IRB), i.e.:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of SSI are collected in this phase. Patients with fractures are enrolled and their standard of care treatment is observed.
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.
Behavioral: Implementation 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
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
Plan to share: No — 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
No publications or documents are linked to this record.
Ran from Dec 2019 to primary completion in Dec 2021, 24 months.
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This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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AO Clinical Investigation and Publishing Documentation