- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04163029
Oral Care Study of Postoperative Infections
June 15, 2020 updated by: Benjamin Javillier, University of Liege
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
Study Overview
Detailed Description
Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Liège, Belgium, 4000
- Recruiting
- University of Liege, University Hospital
-
Contact:
- Benjamin Javillier, MD
- Phone Number: +3243667180
- Email: benjamin.javillier@chuliege.be
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients operated on for transmandibulary buccopharyngectomy with recognition, free flap struction
Description
Inclusion Criteria:
- ENT surgery with free flap reconstruction
Exclusion Criteria:
- Allergy to chlorhexidine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
preoperative oral care
|
tooth brushing and mouthwash with chlorhexidine 0,2% five day before surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of postoperative infections
Time Frame: through study completion, an average of 1 year
|
incidence of postoperative infections
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Javillier, MD, Centre Hospitalier Universitaire de Liege
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2019
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
February 1, 2022
Study Registration Dates
First Submitted
November 11, 2019
First Submitted That Met QC Criteria
November 13, 2019
First Posted (Actual)
November 14, 2019
Study Record Updates
Last Update Posted (Actual)
June 16, 2020
Last Update Submitted That Met QC Criteria
June 15, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAACBPTM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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