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

AO Clinical Investigation and Publishing Documentation

Status: Terminated

Conditions: Surgical Site Infection

Treatments: Behavioral: Implementation of the AO Trauma SSI Prevention Bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT03380273

AOPOSSI

Details and patient eligibility

About

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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Full 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).

Enrollment: 222 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

pre-intervention

No Intervention group

Description:

The number of SSI are collected in this phase. Patients with fractures are enrolled and their standard of care treatment is observed.

post-intervention

Other group

Description:

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.

Treatment:

Behavioral: Implementation of the AO Trauma SSI Prevention Bundle