Cancer, MouthNCT04163029
Oral Care Study of Postoperative Infections
An observational study of Cancer, Mouth, run by University of Liege at 1 site in Belgium.
Trial summary
Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer, Mouth
- What is being tested?
- Preoperative oral care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Dec 2019to 1 Feb 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients operated on for transmandibulary buccopharyngectomy with recognition, free flap struction
Who may be able to join
- ENT surgery with free flap reconstruction
Who cannot join
- Allergy to chlorhexidine
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of Liege, University Hospital
Liège, 4000
Benjamin Javillier, MD, +3243667180, benjamin.javillier@chuliege.be
About this study
Official title: Analysis of the Impact on the Incidence of Postoperative Infections (at the Surgical Site, Flap and Lung) and on the Length of Stay of Oral Care Before Surgery on the ENT Sphere With Flap Reconstruction
Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care
Read the detailed description
Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care
- Conditions
- Cancer, Mouth
- Being tested
- Preoperative oral care
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative oral careProcedure or surgery
tooth brushing and mouthwash with chlorhexidine 0,2% five day before surgery
| Study group | Role | What they receive |
|---|---|---|
| preoperative oral care | Not described Receives: Procedure: Preoperative oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative infections
incidence of postoperative infections
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start22 Dec 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, MouthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, University of Liege
- Investigators
- Benjamin Javillier, MD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163029
- Sponsor's protocol ID
- RAACBPTM
- Status last verified
- Jun 2020
- First submitted
- 11 Nov 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Impact on the Incidence of Postoperative Infections (at the Surgical Site, Flap and Lung) and on the Length of Stay of Oral Care Before Surgery on the ENT Sphere With Flap Reconstruction
- ClinicalTrials.gov ID
- NCT04163029
- Acronym / sponsor ID
- RAACBPTM
- Conditions
- Cancer, Mouth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 22 Dec 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 14 Nov 2019 (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.
Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care
Detailed description
Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preoperative oral care | – | Procedure: Preoperative oral care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients operated on for transmandibulary buccopharyngectomy with recognition, free flap struction
Key inclusion criteria (1 listed)
- ENT surgery with free flap reconstruction
Key exclusion criteria (1 listed)
- Allergy to chlorhexidine
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 |
|---|---|---|
| Preoperative oral caretooth brushing and mouthwash with chlorhexidine 0,2% five day before surgery | Procedure or surgery | preoperative oral care |
Primary outcome
incidence of postoperative infections
Time frame: through study completion, an average of 1 year
incidence of postoperative infections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 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.
Benjamin Javillier, MD principal investigator
Centre Hospitalier Universitaire de Liege
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 Cancer, Mouth, run by University of Liege at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 16 Jun 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Javillier, MD (003243667655, benjamin.javillier@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative infections (time frame: through study completion, an average of 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 16 Jun 2020.