- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04386031
Fungal Infection After Oral Cavity Surgeries
May 21, 2020 updated by: Rambam Health Care Campus
this prospective study we will examine the prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
80
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients > 18 years old, undergoing oral cavity surgery at ENT department and maxillofacial surgery department, Rambam medical center between May 2019-May 2021
Description
Inclusion Criteria:
- Age over 18
Exclusion Criteria:
Previous oral cavity surgery.
- Previous radiotherapy to the head and neck.
- Previous treatment with antifungal drugs in the 30 days preceding the surgery Immunocompomised state at the date of surgery.
- Pregnancy
- Lack of follow-up
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 |
---|---|
group with antifungal drug
|
Throat culture for fungal pathogens will be taken before surgery, at post-operative day (POD) 3 and 2 weeks after the operation
|
A control group
A control group will be taken ,patients undergoing thyroidectomy or parotidectomy
|
Throat culture for fungal pathogens will be taken before surgery, at post-operative day (POD) 3 and 2 weeks after the operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug.
Time Frame: 2 years
|
40 patients undergoing oral cavity surgery and 40 patients (control group) undergoing thyroidectomy or parotidectomy for our research measurement :Throat culture for fungal pathogens
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
May 1, 2022
Study Registration Dates
First Submitted
May 10, 2020
First Submitted That Met QC Criteria
May 10, 2020
First Posted (Actual)
May 13, 2020
Study Record Updates
Last Update Posted (Actual)
May 26, 2020
Last Update Submitted That Met QC Criteria
May 21, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0196-19-RMB CTIL
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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