Effect of Intranasal Mupirocin on Rate of Staphylococcus Aureus Surgical Site Infection Following Cesarean Sections

This study is not yet open for participant recruitment.

Verified June 2010 by Hillel Yaffe Medical Center

Sponsor:

Information provided by:

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT01152593

First received: May 31, 2010

Last updated: June 28, 2010

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	May 31, 2010
Last Updated Date	June 28, 2010
Start Date ^ICMJE	July 2010
Estimated Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 28, 2010)	Reduction of the incidence of surgical site infections after cesarean section [ Time Frame: Four years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01152593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Intranasal Mupirocin on Rate of Staphylococcus Aureus Surgical Site Infection Following Cesarean Sections
Official Title ^ICMJE	Not Provided
Brief Summary	The investigators believe that irradication of nose colonization of staphyloccocus aureus will reduce the incidence of surgical site infections after cesarean section.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Surgical Wound Infection Cesarean Section Staphylococcus Aureus
Intervention ^ICMJE	Drug: Mupirocin Intranasal cream given to patient after confirmation of colonization
Study Arm (s)	Experimental: Intranasal Mupirocin Intervention: Drug: Mupirocin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	400
Estimated Completion Date	December 2014
Estimated Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Women assigned to undergo cesarean section Exclusion Criteria: All others
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01152593
Other Study ID Numbers ^ICMJE	HYMC0033-10
Has Data Monitoring Committee	Not Provided
Responsible Party	Gai Shrem, MD, Hillel Yaffe Medical Center
Study Sponsor ^ICMJE	Hillel Yaffe Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hillel Yaffe Medical Center
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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