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Chlorhexidine Versus Povidone-Iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection

Information source: Ain Shams Maternity Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Surgical Site Infection

Intervention: Chlorhexidine (Drug); Povidone-Iodine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Ain Shams Maternity Hospital

Official(s) and/or principal investigator(s):
AMR YEHIA, MD, MRCOG, Study Director, Affiliation: Ain Shams Maternity Hospital

Overall contact:
AMR YEHIA, MD, MRCOG, Phone: +201227900014, Email: am_helmy77@hotmail.com

Summary

There is no difference between using chlorhexidine-based antisepsis protocol versus povidone-iodine protocol in reduction of surgical site infection in women undergoing cesarean section.

Clinical Details

Official title: Chlorhexidine Versus Povidone-iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection Rate:a Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Surgical site infection within one week after surgery

Secondary outcome:

Surgical site infection within 30 days after surgery

Long hospital stay

Hospital readmission

Febrile morbidity

Detailed description: The aim of this study is to examine the efficacy &safety of Chlorhexidine-based antisepsis protocol versus povidone- iodine protocol used as preoperative skin antisepsis for patients undergoing cesarean section in reduction of surgical site infection. Chlorhexidine is a chemical antiseptic. It is effective on both Gram-positive and Gram-negative bacteria, although it is less effective with some Gram-negative bacteria. It has both bactericidal and bacteriostatic mechanisms of action, the mechanism of action being membrane disruption. Iodine is commonly used as an antiseptic agent clinically. Iodine is usually formulated as an iodophor, which consists of iodine combined with a carrier molecule. This formulation increases the solubility of iodine and provides a reservoir for sustained release. The most commonly used iodophor is povidone iodine which is a 10% iodophor solution that contains 1% available iodine. Iodine molecules penetrate microbial cell walls and cause oxidation of cysteine, iodination of amino acids and unsaturated fatty acids. This leads to reduced protein synthesis and bacterial cell wall damage.

Eligibility

Minimum age: 18 Years. Maximum age: 42 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Patient 18 years of age or older who will undergo cesarean deliveries who are at term (37wks-41wks of gestation). 2. Body mass index (BMI) between 20-35kg/m2. 3. Able to communicate well with the investigator and to comply with the requirements of the entire study. Exclusion Criteria: 1. Rupture of membranes. 2. Patients who have history of allergy to chlorhexidine, alcohol and iodophors. 3. Documented concomitant infections like: Chorioamnionitis, Pyelonephritis, Urinary tract infection, Mastitis.

Locations and Contacts

AMR YEHIA, MD, MRCOG, Phone: +201227900014, Email: am_helmy77@hotmail.com

Ain Shams Maternity Hospital, Cairo 11566, Egypt; Recruiting
AMR YEHIA, MD, MRCOG, Phone: +201227900014, Email: am_helmy77@hotmail.com
Additional Information

Starting date: June 2014
Last updated: March 23, 2015

Page last updated: August 23, 2015

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