Surgical Wound InfectionNCT01152593
Effect of Intranasal Mupirocin on Rate of Staphylococcus Aureus Surgical Site Infection Following Cesarean Sections
A study testing Mupirocin in people with Surgical Wound Infection and Cesarean Section, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The investigators believe that irradication of nose colonization of staphyloccocus aureus will reduce the incidence of surgical site infections after cesarean section. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Surgical Wound Infection, Cesarean Section, Staphylococcus Aureus
- What is being tested?
- Mupirocin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Dec 2014
- Phase
- Interventional
- 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 Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- Women assigned to undergo cesarean section
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Gai Shrem, MD, gais@hy.health.gov.il
Gai Shrem, MD
About this study
The investigators believe that irradication of nose colonization of staphyloccocus aureus will reduce the incidence of surgical site infections after cesarean section.
- Being tested
- Mupirocin
- Medical subject headings
- Surgical Wound Infection, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MupirocinDrug
Intranasal cream given to patient after confirmation of colonization
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Mupirocin | Experimental | Not described Receives: Drug: Mupirocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the incidence of surgical site infections after cesarean section
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152593
- Sponsor's protocol ID
- HYMC0033-10
- Status last verified
- Jun 2010
- First submitted
- 31 May 2010
- Last updated
- 29 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intranasal Mupirocin on Rate of Staphylococcus Aureus Surgical Site Infection Following Cesarean Sections
- ClinicalTrials.gov ID
- NCT01152593
- Acronym / sponsor ID
- HYMC0033-10
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jul 2010
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 29 Jun 2010 (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.
The investigators believe that irradication of nose colonization of staphyloccocus aureus will reduce the incidence of surgical site infections after cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal Mupirocin | Experimental | Drug: Mupirocin |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women assigned to undergo cesarean section
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 |
|---|---|---|
| MupirocinIntranasal cream given to patient after confirmation of colonization | Drug | Intranasal Mupirocin |
Primary outcome
Reduction of the incidence of surgical site infections after cesarean section
Time frame: Four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
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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?
A study testing Mupirocin in people with Surgical Wound Infection and Cesarean Section, 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 29 Jun 2010. 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.
What does the primary outcome measure?
Reduction of the incidence of surgical site infections after cesarean section (time frame: Four 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 29 Jun 2010.