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

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT01975805

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

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 :

Jan 1, 2010

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

May 1, 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

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

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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