AO Multicenter Intervention Trial for Prevention of Surgical Site Infection (AOPOSSI)

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

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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Study Overview

• Status: Terminated
• Conditions: Surgical Site Infection
• Intervention / Treatment: Behavioral: Implementation of the AO Trauma SSI Prevention Bundle

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 Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital Italiano de Buenos Aires
• Germany
  • Gießen, Germany
    • University Hospital Gießen
  • Regensburg, Germany
    • University Hospital Regensburg
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
• Romania
  • Bucuresti, Romania
    • Spitalul Clinic de Urgenta Floreasca
• Spain
  • Sabadell, Spain
    • Hospital Universitari Parc Tauli
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0284
      • University of Kentucky HealthCare
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Missouri Orthopaedic Institute
    • Saint Louis, Missouri, United States, 63110
      • Saint Louis University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Virginia
    • Charlottesville, Virginia, United States, 22908-0159
      • University of Virginia
    • Richmond, Virginia, United States, 23298-0153
      • VCU Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: pre-intervention; 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; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Stephen Kates, MD, VCU Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2019
• Primary Completion (ACTUAL): December 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (ACTUAL): December 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: AOPOSSI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No