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AOPOSSI: AO Multicenter Intervention Trial for Prevention of Surgical Site Infection

Sponsor
AO Clinical Investigation and Publishing Documentation (Other)
Overall Status
Terminated
CT.gov ID
NCT03380273
Collaborator
(none)
222
Enrollment
14
Locations
2
Arms
24.8
Actual Duration (Months)
15.9
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Implementation of the AO Trauma SSI Prevention Bundle
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
222 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention 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.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.
Primary Purpose:
Prevention
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
Actual Study Start Date :
Dec 6, 2019
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: pre-intervention

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

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

Outcome Measures

Primary Outcome Measures

  1. Infection Rate [within 3 months after surgery]

    Surgical site infection rate as defined by CDC or FRI definition

Secondary Outcome Measures

  1. Implementation success of the AOT SSI Prevention Bundle [up to 48 months]

    Compliance rate for each measure of the bundle before and after the intervention

  2. Evaluation of attitudes, perception and knowledge concerning SSI [up to 48 months]

    Cross sectional survey of surgeons at participating sites performed before and after the implementation of the AOT SSI Prevention Bundle

  3. Surgeon satisfaction [up to 48 months]

    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

  4. Health-economic analysis [up to 48 months]

    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.).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cedars Sinai Medical Center Los Angeles California United States 90048
2 University of Kentucky Healthcare Lexington Kentucky United States 40536-0284
3 UMass Memorial Medical Center Worcester Massachusetts United States 01655
4 Missouri Orthopaedic Institute Columbia Missouri United States 65212
5 Saint Louis University Saint Louis Missouri United States 63110
6 University of Pennsylvania Philadelphia Pennsylvania United States 19104
7 University of Virginia Charlottesville Virginia United States 22908-0159
8 VCU Medical Center Richmond Virginia United States 23298-0153
9 Hospital Italiano de Buenos Aires Buenos Aires Argentina
10 University Hospital Gießen Gießen Germany
11 University Hospital Regensburg Regensburg Germany
12 Korea University Guro Hospital Seoul Korea, Republic of
13 Spitalul Clinic de Urgenta Floreasca Bucuresti Romania
14 Hospital Universitari Parc Tauli Sabadell Spain

Sponsors and Collaborators

  • AO Clinical Investigation and Publishing Documentation

Investigators

  • Principal Investigator: Stephen Kates, MD, VCU Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AO Clinical Investigation and Publishing Documentation
ClinicalTrials.gov Identifier:
NCT03380273
Other Study ID Numbers:
  • AOPOSSI
First Posted:
Dec 21, 2017
Last Update Posted:
Jan 18, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Communicable Diseases
Surgical Wound Infection

Study Results

No Results Posted as of Jan 18, 2022