AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

Surgical Site Infection Clinical Trial

— AOPOSSI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03380273
• Other study ID #: AOPOSSI
• Status: Terminated
• Phase: N/A
• Start date: December 6, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 222
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Germany	University Hospital Gießen	Gießen
Germany	University Hospital Regensburg	Regensburg
Korea, Republic of	Korea University Guro Hospital	Seoul
Romania	Spitalul Clinic de Urgenta Floreasca	Bucuresti
Spain	Hospital Universitari Parc Tauli	Sabadell
United States	University of Virginia	Charlottesville	Virginia
United States	Missouri Orthopaedic Institute	Columbia	Missouri
United States	University of Kentucky Healthcare	Lexington	Kentucky
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	VCU Medical Center	Richmond	Virginia
United States	Saint Louis University	Saint Louis	Missouri
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

United States,  Argentina,  Germany,  Korea, Republic of,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection Rate	Surgical site infection rate as defined by CDC or FRI definition	within 3 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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