AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

NCT03380273 | Terminated

• 1 other identifier: AOPOSSI
• Study Type: interventional
• Target: 222
• Locations: 6 countries
• Sites: 14

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. D

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Infection Rate

  Surgical site infection rate as defined by CDC or FRI definition

  within 3 months after surgery

Secondary Outcomes (4)

• Implementation success of the AOT SSI Prevention Bundle

  up to 48 months

• Evaluation of attitudes, perception and knowledge concerning SSI

  up to 48 months

• Surgeon satisfaction

  up to 48 months

• Health-economic analysis

  up to 48 months

Study Arms (2)

pre-intervention

NO INTERVENTION

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

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

Interventions

Implementation of the AO Trauma SSI Prevention Bundle 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

post-intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead

Study Sites (14)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Kentucky Healthcare

Lexington, Kentucky, 40536-0284, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Missouri Orthopaedic Institute

Columbia, Missouri, 65212, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Virginia

Charlottesville, Virginia, 22908-0159, United States

Location

VCU Medical Center

Richmond, Virginia, 23298-0153, United States

Location

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

University Hospital Gießen

Giessen, Germany

Location

University Hospital Regensburg

Regensburg, Germany

Location

Spitalul Clinic de Urgenta Floreasca

Bucharest, Romania

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Hospital Universitari Parc Tauli

Sabadell, Spain

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Kates, MD

  VCU Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: It is that preventino measures are enforced in the hospital. This will apply to all patients and no masking is required.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 21, 2017
• Study Start: December 6, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: January 18, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); DE (2); AR (1); RO (1); KR (1); ES (1)