NCT00528008

Brief Summary

The purpose of this study is to find out if chlorhexidine gluconate solution is better at reducing the rate of wound infection after cesarean section compared to povidone-iodine.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
268

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
terminated

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

September 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

September 10, 2007

Last Update Submit

November 8, 2012

Conditions

Wound Infection

Keywords

infectionsepsispovidone-iodinechlorhexidine gluconatefevererythemaleukocytosisdrainagevaginal dischargeelective cesarean section

Outcome Measures

Primary Outcomes (1)

  • to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate

    within 6 weeks following surgery

Secondary Outcomes (5)

  • readmission to hospital

    within 6 weeks following surgery

  • extended length of admission

    within 6 weeks following surgery

  • need for intravenous antibiotics

    within 6 weeks following surgery

  • need for repeat procedure such as drainage

    within 6 weeks following surgery

  • increased outpatient surveillance

    within 6 weeks following surgery

Study Arms (2)

A

ACTIVE COMPARATOR

povidone-iodine

Other: povidone-iodine solution

B

ACTIVE COMPARATOR

chlorhexidine gluconate

Other: chlorhexidine gluconate

Interventions

povidone-iodine solutionOTHER

Abdominal surgical field cleaned with 5% povidone-iodine detergent scrub, detergent cleaned from surgical area with sterile water, and then painted with 1% povidone-iodine solution.

Also known as: Betadine, Povidone, Minidyne
A
chlorhexidine gluconateOTHER

Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.

Also known as: Dexidine, Avagard, Bactoshield
B

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>19 years
  • Gestational age \> 37 weeks
  • Booked elective cesarean section

You may not qualify if:

  • Gestational age \< 37 weeks
  • Premature rupture of membranes
  • Onset of labor prior to procedure
  • Evidence of maternal sepsis; maternal fever \> 38.5C
  • LSCS for emergency issues: non-reassuring fetal status, placental abruption, failed induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women' s Health Centre, Eastern Health

St. John's, Newfoundland and Labrador, A1E 5K9, Canada

Location

MeSH Terms

Conditions

Wound InfectionInfectionsSepsisFeverErythemaLeukocytosisVaginal Discharge

Interventions

Povidone-IodinePovidonechlorhexidine gluconateChlorhexidine

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBody Temperature ChangesSigns and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureBiguanidesGuanidinesAmidines

Study Officials

  • Paula Mallaley, MD

    Resident, Obstetrics and Gynecology, Memorial University of Newfoundland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 11, 2007

Study Start

December 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

CA(1)