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

NCT ID: NCT01975805

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Pregnancy Cesarean Section

Keywords

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cesarean delivery chlorhexidine iodine skin disinfectant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chlorhexidine Gluconate

Use of Chlorhexidine Gluconate as skin disinfectant for cesarean section.

Group Type EXPERIMENTAL

Chlorhexidine Gluconate

Intervention Type OTHER

Povidone Iodine

Use of Povidone Iodine as skin disinfectant for cesarean section.

Group Type EXPERIMENTAL

Povidone Iodine

Intervention Type OTHER

Interventions

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Chlorhexidine Gluconate

Intervention Type OTHER

Povidone Iodine

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Ramen Chmait

Assistant Professor of Clinical Obstetrics&Gynecology, Pediatrics, and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynelle M. Kunkle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Ramen Chmait, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32580252 (View on PubMed)

Other Identifiers

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HS-09-00380

Identifier Type: OTHER

Identifier Source: secondary_id

FTP-09-00380

Identifier Type: -

Identifier Source: org_study_id