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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, California

University of Southern California

Los Angeles, California, United States, 90027

Sponsors and Collaborators

University of Southern California

Investigators

• Principal Investigator: Cynelle M. Kunkle, MD; University of Southern California
• Principal Investigator: Ramen Chmait, MD; University of Southern California

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: November 5, 2013
• Last Verified: October 2013

Keywords provided by Ramen Chmait, University of Southern California:

cesarean delivery; chlorhexidine; iodine; skin disinfectant

Additional relevant MeSH terms:

Chlorhexidine; Chlorhexidine gluconate; Povidone-Iodine; Povidone; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Dermatologic Agents; Plasma Substitutes; Blood Substitutes