NCT01152593

Brief Summary

The investigators believe that irradication of nose colonization of staphyloccocus aureus will reduce the incidence of surgical site infections after cesarean section.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2010

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

4 years

First QC Date

May 31, 2010

Last Update Submit

June 28, 2010

Conditions

Surgical Wound InfectionCesarean SectionStaphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

  • Reduction of the incidence of surgical site infections after cesarean section

    Four years

Study Arms (1)

Intranasal Mupirocin

EXPERIMENTAL
Drug: Mupirocin

Interventions

MupirocinDRUG

Intranasal cream given to patient after confirmation of colonization

Intranasal Mupirocin

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women assigned to undergo cesarean section

You may not qualify if:

  • All others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Surgical Wound InfectionStaphylococcal Infections

Interventions

Mupirocin

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Epoxy CompoundsEthers, CyclicEthersOrganic ChemicalsPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 31, 2010

First Posted

June 29, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations

IL(1)