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Chlorhexidine Gluconate Versus Povidone Iodine at Cesarean Delivery: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT01975805
Recruitment Status : Completed
First Posted : November 5, 2013
Last Update Posted : November 5, 2013
Information provided by (Responsible Party):
Ramen Chmait, University of Southern California

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.

Condition or disease Intervention/treatment Phase
Pregnancy Cesarean Section Other: Chlorhexidine Gluconate Other: Povidone Iodine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Determine the Difference in Positive Bacterial Cultures in Cesarean Sections With 2% Chlorhexidine- Gluconate, 70% Isopropyl Alcohol (Chloraprep) vs. Povidone-iodine 10% (Betadine) Preoperative Surgical Scrub
Study Start Date : January 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: Chlorhexidine Gluconate
Use of Chlorhexidine Gluconate as skin disinfectant for cesarean section.
Other: Chlorhexidine Gluconate
Experimental: Povidone Iodine
Use of Povidone Iodine as skin disinfectant for cesarean section.
Other: Povidone Iodine

Primary Outcome Measures :
  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. [ Time Frame: 3 min-18 days after skin preparation ]

Secondary Outcome Measures :
  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. [ Time Frame: Post operative days 0-18 ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975805

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United States, California
University of Southern California
Los Angeles, California, United States, 90027
Sponsors and Collaborators
University of Southern California
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Principal Investigator: Cynelle M. Kunkle, MD University of Southern California
Principal Investigator: Ramen Chmait, MD University of Southern California
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ramen Chmait, Assistant Professor of Clinical Obstetrics&Gynecology, Pediatrics, and Surgery, University of Southern California
ClinicalTrials.gov Identifier: NCT01975805    
Other Study ID Numbers: FTP-09-00380
HS-09-00380 ( Other Identifier: USC )
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: October 2013
Keywords provided by Ramen Chmait, University of Southern California:
cesarean delivery
skin disinfectant
Additional relevant MeSH terms:
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Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Plasma Substitutes
Blood Substitutes