Clinical trial NCT03380273: AO Multicenter Intervention Trial for Prevention of Surgical Site Infection
Official title: AO Multicenter Intervention Trial to Evaluate the Impact of a Bundle of Measures for the Prevention of Surgical Site Infection in Fracture Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: PREVENTION

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.

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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).

Eligibility criteria: 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

Primary outcomes:
measure: Infection Rate
timeFrame: within 3 months after surgery
Secondary outcomes:
measure: Implementation success of the AOT SSI Prevention Bundle
timeFrame: up to 48 months
measure: Evaluation of attitudes, perception and knowledge concerning SSI
timeFrame: up to 48 months
measure: Surgeon satisfaction
timeFrame: up to 48 months
measure: Health-economic analysis
timeFrame: up to 48 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Lexington
country: United States
facility: University of Kentucky Healthcare
state: Kentucky
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Gießen
country: Germany
facility: University Hospital Gießen
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta Floreasca
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
Study officials:
affiliation: VCU Health
name: Stephen Kates, MD
role: PRINCIPAL_INVESTIGATOR
References: