AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

Not Applicable

Terminated

• Conditions: Surgical Site Infection

• Registration Number: NCT03380273
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

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).

Study Timeline

• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-21
• Study Start: 2019-12-06
• Status Verified: 2021-12
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Infection Rate	within 3 months after surgery	Surgical site infection rate as defined by CDC or FRI definition

Secondary Outcome Measures

Name	Time	Method
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
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
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.).
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

Trial Locations

Locations (14)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Kentucky Healthcare; 🇺🇸 Lexington, Kentucky, United States

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

Missouri Orthopaedic Institute; 🇺🇸 Columbia, Missouri, United States

Saint Louis University; 🇺🇸 Saint Louis, Missouri, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

VCU Medical Center; 🇺🇸 Richmond, Virginia, United States

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

University Hospital Gießen; 🇩🇪 Gießen, Germany

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