Rate of InfectionsSSI-flapNCT04492826
Postoperative Surgical Site Infection afterENT Bone Flap Surgery
An observational study of Rate of Infections and Operating Site, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In 2017, the French Society in anesthesia and reanimation published new recommendations on intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis applies to any otolaryngology surgery, regardless of patient's medical history or type of flap used to rebuild. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rate of Infections, Operating Site, Post-operative Surgery
- What is being tested?
- Postoperative infections rate
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Feb 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient operated on for bone flap surgery by the Otorhinolaryngology surgery team in Croix-Rousse hospital (Pr CERUSE)
Who may be able to join
- Patient operated for bone flap in Croix-Rousse hospital, in otorhinolaryngology department, since september 2012 and until January 2019
Who cannot join
- patient's opposition to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Occurrence of Postoperative Surgical Site Infection in Otolaryngology Flap Surgery With Bone Graft, a Retrospective Analytic Study Between 2012 and 2019
In 2017, the French Society in anesthesia and reanimation published new recommendations on intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis applies to any otolaryngology surgery, regardless of patient's medical history or type of flap used to rebuild. This has resulted in an alignment of our local protocol in Croix-Rousse hospital.
However, after few years, our local impressions are that bone flap surgeries are very likely to provide surgical site infections (osteo-articular or non-osteo-articular infections).
Read more
The prejudice of these postoperative site infections is significant, with serious consequences,. of both functional and aesthetic sides.
We wanted to objectify this impression by retrospectively analyzing the data relating to patients operated on for bone flapsurgeries.
Knowing the operation site infection rate after surgery for otolaryngology bone flap surgery will allow us to objectively understand the infectious risk of these surgeries, in particular the risk of osteoarticular infection. Identifying operation site infection factors will allow us to better target and prevent them.
The goal is to find out if the antibiotic prophylaxis currently recommended is sufficient and effective for this type of surgery.
- Conditions
- Rate of Infections, Operating Site, Post-operative Surgery, Bone Flap Surgery, Otolaryngology
- Being tested
- Postoperative infections rate
- Keywords
- bone flap surgery, postoperative surgical infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative infections rateProcedure or surgery
Assess the postoperative infection rate after otolaryngology bone flap surgery.
| Study group | Role | What they receive |
|---|---|---|
| Infected patients | patients with bone flap surgeries Receives: Procedure: Postoperative infections rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative infections rate after otolaryngology bone flap surgery
Assess the postoperative infection rate after bone flap otolaryngology surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study startSep 2012
- Primary completionSep 2012
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rate of InfectionsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492826
- Sponsor's protocol ID
- 20_5052
- Acronym
- SSI-flap
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Occurrence of Postoperative Surgical Site Infection in Otolaryngology Flap Surgery With Bone Graft, a Retrospective Analytic Study Between 2012 and 2019
- ClinicalTrials.gov ID
- NCT04492826
- Acronym / sponsor ID
- SSI-flap / 20_5052
- Conditions
- Rate of Infections, Operating Site, Post-operative Surgery, Bone Flap Surgery, Otolaryngology
- Keywords
- bone flap surgery, postoperative surgical infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 30 Jul 2020 (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.
In 2017, the French Society in anesthesia and reanimation published new recommendations on intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis applies to any otolaryngology surgery, regardless of patient's medical history or type of flap used to rebuild. This has resulted in an alignment of our local protocol in Croix-Rousse hospital.
However, after few years, our local impressions are that bone flap surgeries are very likely to provide surgical site infections (osteo-articular or non-osteo-articular infections).
The prejudice of these postoperative site infections is significant, with serious consequences,. of both functional and aesthetic sides.
We wanted to objectify this impression by retrospectively analyzing the data relating to patients operated on for bone flapsurgeries.
Knowing the operation site infection rate after surgery for otolaryngology bone flap surgery will allow us to objectively understand the infectious risk of these surgeries, in particular the risk of osteoarticular infection. Identifying operation site infection factors will allow us to better target and prevent them.
The goal is to find out if the antibiotic prophylaxis currently recommended is sufficient and effective for this type of surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infected patients | – | Procedure: Postoperative infections ratepatients with bone flap surgeries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient operated on for bone flap surgery by the Otorhinolaryngology surgery team in Croix-Rousse hospital (Pr CERUSE)
Key inclusion criteria (1 listed)
- Patient operated for bone flap in Croix-Rousse hospital, in otorhinolaryngology department, since september 2012 and until January 2019
Key exclusion criteria (1 listed)
- patient's opposition to participate in the study
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 |
|---|---|---|
| Postoperative infections rateAssess the postoperative infection rate after otolaryngology bone flap surgery. | Procedure or surgery | Infected patients |
Primary outcome
Postoperative infections rate after otolaryngology bone flap surgery
Time frame: 1 year
Assess the postoperative infection rate after bone flap otolaryngology surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rate of Infections and Operating Site, run by Hospices Civils de Lyon at 1 site in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative infections rate after otolaryngology bone flap surgery (time frame: 1 year). 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 30 Jul 2020.