Prevalence of Fungal Infection in Patients Undergoing Oral Cavity Surgery Without Treatment With Antifungal DrugNCT04386031
Fungal Infection After Oral Cavity Surgeries
An observational study of Prevalence of Fungal Infection in Patients Undergoing Oral Cavity Surgery Without Treatment With Antifungal Drug, run by Rambam Health Care Campus.
Trial summary
this prospective study we will examine the prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevalence of Fungal Infection in Patients Undergoing Oral Cavity Surgery Without Treatment With Antifungal Drug
- What is being tested?
- Throat culture for fungal pathogens
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 May 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 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Age over 18
Who cannot join
- 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
About this study
this prospective study we will examine the prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug
- Being tested
- Throat culture for fungal pathogens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Throat culture for fungal pathogensDiagnostic test
Throat culture for fungal pathogens will be taken before surgery, at post-operative day (POD) 3 and 2 weeks after the operation
| Study group | Role | What they receive |
|---|---|---|
| group with antifungal drug | Not described Receives: Diagnostic Test: Throat culture for fungal pathogens | |
| A control group | A control group will be taken ,patients undergoing thyroidectomy or parotidectomy Receives: Diagnostic Test: Throat culture for fungal pathogens |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug.
40 patients undergoing oral cavity surgery and 40 patients (control group) undergoing thyroidectomy or parotidectomy for our research measurement :Throat culture for fungal pathogens
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevalence of Fungal Infection in Patients Undergoing Oral Cavity Surgery Without Treatment With Antifungal DrugStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386031
- Sponsor's protocol ID
- 0196-19-RMB CTIL
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fungal Infection After Oral Cavity Surgeries
- ClinicalTrials.gov ID
- NCT04386031
- Acronym / sponsor ID
- 0196-19-RMB CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 13 May 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.
this prospective study we will examine the prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with antifungal drug | – | Diagnostic Test: Throat culture for fungal pathogens |
| A control group | – | Diagnostic Test: Throat culture for fungal pathogensA control group will be taken ,patients undergoing thyroidectomy or parotidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Age over 18
Key exclusion criteria (5 listed)
- Previous oral cavity surgery.
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 |
|---|---|---|
| Throat culture for fungal pathogensThroat culture for fungal pathogens will be taken before surgery, at post-operative day (POD) 3 and 2 weeks after the operation | Diagnostic test | A control group, group with antifungal drug |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevalence of Fungal Infection in Patients Undergoing Oral Cavity Surgery Without Treatment With Antifungal Drug, run by Rambam Health Care Campus.
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 5 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 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
prevalence of fungal infection in patients undergoing oral cavity surgery without treatment with antifungal drug. (time frame: 2 years). 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 26 May 2020.