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

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.

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

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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