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 surgeryLong 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
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