NCT01975805

Brief Summary

Currently there are no published studies comparing the efficacy of Chloraprep and povidone-iodine in decreasing postoperative- wound infection in cesarean sections. However, there have been studies involving other types of surgery that have compared the efficacy of different types of preoperative cleansing agents in preventing postoperative wound infection. These studies have shown that controversy exists over which antiseptic skin preparation is the most effective for preventing postoperative surgical wound infections. The standard of care at Los Angeles County Hospital for preoperative skin antiseptic in cesarean sections is povidone- iodine 10% (betadine), however many other hospitals have made the transition to using Chloraprep. In an attempt to improve on the current standard of care, we propose a quality improvement prospective randomized study to compare the difference in postoperative wound complications with the use of povidone- iodine and Chloraprep as a preoperative antiseptic in cesarean sections. We hypothesize that Chloraprep will be better than Betadine at reducing the incidence of positive bacterial cultures following cesarean sections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
Last Updated

November 5, 2013

Status Verified

October 1, 2013

Enrollment Period

2.2 years

First QC Date

October 23, 2013

Last Update Submit

October 28, 2013

Conditions

PregnancyCesarean Section

Keywords

cesarean deliverychlorhexidineiodineskin disinfectant

Outcome Measures

Primary Outcomes (1)

  • To compare the difference in the number of positive bacterial cultures at the site of the incision after preoperative cleansing with povidone iodine and Chloraprep.

    3 min-18 days after skin preparation

Secondary Outcomes (1)

  • To compare the difference in postoperative wound infections measured by the presence of purulent drainage, temp greater than 100.4 F, induration at the site of incision with the use of povidone-iodine and Chloraprep.

    Post operative days 0-18

Study Arms (2)

Chlorhexidine Gluconate

EXPERIMENTAL

Use of Chlorhexidine Gluconate as skin disinfectant for cesarean section.

Other: Chlorhexidine Gluconate

Povidone Iodine

EXPERIMENTAL

Use of Povidone Iodine as skin disinfectant for cesarean section.

Other: Povidone Iodine

Interventions

Chlorhexidine GluconateOTHER
Chlorhexidine Gluconate
Povidone IodineOTHER
Povidone Iodine

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women greater than 36 weeks gestation presenting for scheduled repeat cesarean sections and scheduled primary cesarean sections
  • Ages 18-45
  • Written informed consent obtained

You may not qualify if:

  • Patients who are taking antimicrobial therapy for any reason
  • Patient with a known allergy to one or both of the prepping agents
  • Patients currently taking immunosuppressant drugs
  • Active acute or chronic infection
  • Current history of cancer
  • Open wounds, skin ulcers, sores, and severe acne
  • History of methicillin-resistant staphylococcus aureus colonization or oxacillin-resistant staphylococcus aureus colonization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90027, United States

Location

Related Publications (1)

  • Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5.

    PMID: 32580252DERIVED

MeSH Terms

Interventions

chlorhexidine gluconatePovidone-Iodine

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Cynelle M. Kunkle, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Ramen Chmait, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Obstetrics&Gynecology, Pediatrics, and Surgery

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 5, 2013

Study Start

January 1, 2010

Primary Completion

March 1, 2012

Study Completion

May 1, 2012

Last Updated

November 5, 2013

Record last verified: 2013-10

Locations

US(1)