AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

NCT ID: NCT03380273

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-06
• Study Completion Date: 2021-12-31

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).

Conditions

Surgical Site Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

pre-intervention

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: OTHER

Implementation of the AO Trauma SSI Prevention Bundle

Intervention Type: BEHAVIORAL

AOT SSI Prevention Bundle

Preventive measure

1. Antibiotic prophylaxis

2. Perioperative antibiotics

3. Oxygen administration

4. Patient temperature

5. Surgeon protective wear

6. Patient operative skin preparation

7. Suction drains

8. Blood glucose level

9. Red cell transfusion

10. Dressing changes

Interventions

Implementation of the AO Trauma SSI Prevention Bundle

AOT SSI Prevention Bundle

Preventive measure

1. Antibiotic prophylaxis

2. Perioperative antibiotics

3. Oxygen administration

4. Patient temperature

5. Surgeon protective wear

6. Patient operative skin preparation

7. Suction drains

8. Blood glucose level

9. Red cell transfusion

10. Dressing changes

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Kates, MD

Role: PRINCIPAL_INVESTIGATOR

VCU Health

Locations

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

St 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

University Hospital Regensburg

Regensburg, , Germany

Spitalul Clinic de Urgenta Floreasca

Bucharest, , Romania

Korea University Guro Hospital

Seoul, , South Korea

Hospital Universitari Parc Tauli

Sabadell, , Spain

Countries

United States; Argentina; Germany; Romania; South Korea; Spain

Other Identifiers

AOPOSSI

Identifier Type: -

Identifier Source: org_study_id