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

Not Applicable

Completed

• Conditions: Cesarean Section; Pregnancy
• Interventions: Other: Chlorhexidine Gluconate; Other: Povidone Iodine

• Registration Number: NCT01975805
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Status Verified: 2013-10
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-28
• Last Update Submitted: 2013-10-28
• Study First Posted: 2013-11-05
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine Gluconate	Chlorhexidine Gluconate	Use of Chlorhexidine Gluconate as skin disinfectant for cesarean section.
Povidone Iodine	Povidone Iodine	Use of Povidone Iodine as skin disinfectant for cesarean section.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States