Staphylococcal InfectionsNCT00646919
Preoperative Nasal Swabs From Pediatric Patients
An observational study of Staphylococcal Infections, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
We intend to take a nasal swab from each pediatric pre-operative patient in our out-clinic with the intention of looking for a connection between positive operative incisions and a positive nasal swab. The patients will be in the out-patient clinic for a few hours, and will be examined post-operatively after one week. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- Nose swab
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: All pediatric patients attending our outpatient surgery clinic
Who may be able to join
- All pediatric patients attending outpatient surgery clinic
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Gershon Keren, MD, 972-4-6304218, gershonk@hy.health.gov.il
Zvi Steiner, MD
About this study
Official title: Double-Blind Prospective Study Concerning the Connection Between Positive Nasal Culture for Staphyloccoci in Pediatric Patients Undergoing Any Elective Surgery in the Out-Patient Clinic in the Hillel Yaffe Medical Center, Over a Period of One Year
We intend to take a nasal swab from each pediatric pre-operative patient in our out-clinic with the intention of looking for a connection between positive operative incisions and a positive nasal swab. The patients will be in the out-patient clinic for a few hours, and will be examined post-operatively after one week. Those with positive nasal swabs will be advised to apply a nasal cream (Mupirocin)in their noses for one week. Our hypothesis is that there is a correlation between positive nasal swabs and positive incision infections.
- Conditions
- Staphylococcal Infections
- Being tested
- Nose swab
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nose swabProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | All pre-operative pediatric patients in our outpatient clinic Receives: Procedure: Nose swab |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies 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
- Case only
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646919
- Sponsor's protocol ID
- HY56/2007
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 31 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Prospective Study Concerning the Connection Between Positive Nasal Culture for Staphyloccoci in Pediatric Patients Undergoing Any Elective Surgery in the Out-Patient Clinic in the Hillel Yaffe Medical Center, Over a Period of One Year
- ClinicalTrials.gov ID
- NCT00646919
- Acronym / sponsor ID
- HY56/2007
- Conditions
- Staphylococcal Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- First posted
- 31 Mar 2008 (estimated)
- 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.
We intend to take a nasal swab from each pediatric pre-operative patient in our out-clinic with the intention of looking for a connection between positive operative incisions and a positive nasal swab. The patients will be in the out-patient clinic for a few hours, and will be examined post-operatively after one week. Those with positive nasal swabs will be advised to apply a nasal cream (Mupirocin)in their noses for one week. Our hypothesis is that there is a correlation between positive nasal swabs and positive incision infections.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Nose swabAll pre-operative pediatric patients in our outpatient clinic |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All pediatric patients attending our outpatient surgery clinic
Key inclusion criteria (1 listed)
- All pediatric patients attending outpatient surgery clinic
Key exclusion criteria (1 listed)
- All others
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 |
|---|---|---|
| Nose swab | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2008.
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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.
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 Staphylococcal Infections, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 31 Mar 2008. 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 31 Mar 2008.