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

University of Southern California

Status: Completed

Conditions: Cesarean Section; Pregnancy

Treatments: Other: Povidone Iodine; Other: Chlorhexidine Gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT01975805

HS-09-00380 (Other Identifier)

FTP-09-00380

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Chlorhexidine Gluconate

Experimental group

Description:

Use of Chlorhexidine Gluconate as skin disinfectant for cesarean section.

Treatment:

Other: Chlorhexidine Gluconate

Povidone Iodine

Experimental group

Description:

Use of Povidone Iodine as skin disinfectant for cesarean section.

Treatment:

Other: Povidone Iodine