AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

Study Overview
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Brief Summary
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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. D

Detailed Description
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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).

Official Title
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AO Multicenter Intervention Trial to Evaluate the Impact of a Bundle of Measures for the Prevention of Surgical Site Infection in Fracture Patients

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Behavioral: Implementation of the AO Trauma SSI Prevention Bundle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: pre-intervention<br>The number of SSI are collected in this phase. Patients with fractures are enrolled and their standard of care treatment is observed. | |
| Other: post-intervention<br>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<br>* AOT SSI Prevention Bundle Preventive measure Antibiotic prophylaxis Perioperative antibiotics Oxygen administration Patient temperature Surgeon protective wear Patient operative skin preparation Suction drains Blood glucose level Red cell transfusion Dressing changes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Rate | Surgical site infection rate as defined by CDC or FRI definition | within 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |