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

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02396329
• Other study ID #: antisepsis 1
• Status: Recruiting
• Phase: Phase 2
• First received: March 1, 2015
• Last updated: March 23, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: March 2015
• Source: Ain Shams Maternity Hospital
• Contact: AMR YEHIA, MD, MRCOG
• Phone: +201227900014
• Email: am_helmy77[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 410
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Chlorhexidine

• Povidone-Iodine

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection within one week after surgery		One week	Yes
Secondary	Surgical site infection within 30 days after surgery		in 30 days	Yes
Secondary	Long hospital stay	hospital admission for more than 5 days	30 days	Yes
Secondary	Hospital readmission	readmission due to sepsis	30 days	Yes
Secondary	Febrile morbidity	an oral temperature of 38.0 degree Celsius)or more on any two of the first 10 days postpartum, exclusive of the first 24 hours	10 days	Yes