Surgical Site InfectionAOPOSSINCT03380273
AO Multicenter Intervention Trial for Prevention of Surgical Site Infection
A study testing Implementation of the AO Trauma SSI Prevention Bundle in people with Surgical Site Infection, run by AO Clinical Investigation and Publishing Documentation at 14 sites in 6 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Implementation of the AO Trauma SSI Prevention Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 6 Dec 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
United States8 sites
University of Virginia
Charlottesville, Virginia, 22908-0159
Missouri Orthopaedic Institute
Columbia, Missouri, 65212
University of Kentucky Healthcare
Lexington, Kentucky, 40536-0284
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
VCU Medical Center
Richmond, Virginia, 23298-0153
Saint Louis University
St Louis, Missouri, 63110
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Germany2 sites
University Hospital Gießen
Giessen
University Hospital Regensburg
Regensburg
About this study
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
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
Read the 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
- Being tested
- Implementation of the AO Trauma SSI Prevention Bundle
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of the AO Trauma SSI Prevention BundleBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Implementation of the AO Trauma SSI Prevention Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rate
Surgical site infection rate as defined by CDC or FRI definition
Measured: within 3 months after surgery
Secondary outcomes (4)
Implementation success of the AOT SSI Prevention Bundle
Compliance rate for each measure of the bundle before and after the intervention
Measured: up to 48 months
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
Measured: up to 48 months
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
Measured: up to 48 months
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.).
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start6 Dec 2019
- Primary completion30 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Patient enrollment too small and slow due to pandemic situation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Kates, MD, Principal investigator, VCU Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380273
- Sponsor's protocol ID
- AOPOSSI
- Acronym
- AOPOSSI
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2017
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03380273
- Acronym / sponsor ID
- AOPOSSI / AOPOSSI
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient enrollment too small and slow due to pandemic situation
- Enrolment
- 222 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Implementation of the AO Trauma SSI Prevention BundleHere 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • Age > 18 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of the AO Trauma SSI Prevention BundleAOT 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 | Behavioural | post-intervention |
Primary outcome
Infection Rate
Time frame: within 3 months after surgery
Surgical site infection rate as defined by CDC or FRI definition
4 secondary outcomes
Implementation success of the AOT SSI Prevention Bundle
Time frame: up to 48 months
Evaluation of attitudes, perception and knowledge concerning SSI
Time frame: up to 48 months
Surgeon satisfaction
Time frame: up to 48 months
Health-economic analysis
Time frame: up to 48 months
Results and safety
The study was stopped early (reason given: Patient enrollment too small and slow due to pandemic situation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kates, MD principal investigator
VCU Health
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of the AO Trauma SSI Prevention Bundle in people with Surgical Site Infection, run by AO Clinical Investigation and Publishing Documentation at 14 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Germany, Argentina, Romania, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patient enrollment too small and slow due to pandemic situation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection Rate (time frame: within 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.