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

Primary Purpose

Surgical Site Infection

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implementation of the AO Trauma SSI Prevention Bundle
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cedars Sinai Medical Center
  • University of Kentucky Healthcare
  • UMass Memorial Medical Center
  • Missouri Orthopaedic Institute
  • Saint Louis University
  • University of Pennsylvania
  • University of Virginia
  • VCU Medical Center
  • Hospital Italiano de Buenos Aires
  • University Hospital Gießen
  • University Hospital Regensburg
  • Korea University Guro Hospital
  • Spitalul Clinic de Urgenta Floreasca
  • Hospital Universitari Parc Tauli

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

pre-intervention

post-intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Infection Rate
Surgical site infection rate as defined by CDC or FRI definition

Secondary Outcome Measures

Implementation success of the AOT SSI Prevention Bundle
Compliance rate for each measure of the bundle before and after the intervention
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
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
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.).

Full Information

First Posted
December 15, 2017
Last Updated
January 14, 2022
Sponsor
AO Clinical Investigation and Publishing Documentation
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1. Study Identification

Unique Protocol Identification Number
NCT03380273
Brief Title
AO Multicenter Intervention Trial for Prevention of Surgical Site Infection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Patient enrollment too small and slow due to pandemic situation
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
It is that preventino measures are enforced in the hospital. This will apply to all patients and no masking is required.
Allocation
Non-Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pre-intervention
Arm Type
No Intervention
Arm Description
The number of SSI are collected in this phase. Patients with fractures are enrolled and their standard of care treatment is observed.
Arm Title
post-intervention
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Implementation of the AO Trauma SSI Prevention Bundle
Intervention Description
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
Primary Outcome Measure Information:
Title
Infection Rate
Description
Surgical site infection rate as defined by CDC or FRI definition
Time Frame
within 3 months after surgery
Secondary Outcome Measure Information:
Title
Implementation success of the AOT SSI Prevention Bundle
Description
Compliance rate for each measure of the bundle before and after the intervention
Time Frame
up to 48 months
Title
Evaluation of attitudes, perception and knowledge concerning SSI
Description
Cross sectional survey of surgeons at participating sites performed before and after the implementation of the AOT SSI Prevention Bundle
Time Frame
up to 48 months
Title
Surgeon satisfaction
Description
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
Time Frame
up to 48 months
Title
Health-economic analysis
Description
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.).
Time Frame
up to 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Kates, MD
Organizational Affiliation
VCU Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Kentucky Healthcare
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Missouri Orthopaedic Institute
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908-0159
Country
United States
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0153
Country
United States
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
University Hospital Gießen
City
Gießen
Country
Germany
Facility Name
University Hospital Regensburg
City
Regensburg
Country
Germany
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Spitalul Clinic de Urgenta Floreasca
City
Bucuresti
Country
Romania
Facility Name
Hospital Universitari Parc Tauli
City
Sabadell
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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

Learn more about this trial

AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

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