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

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

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.

Study Overview

• Status: Unknown
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: Chlorhexidine; Drug: Povidone-Iodine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 410
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AMR YEHIA, MD, MRCOG; Phone Number: +201227900014; Email: am_helmy77@hotmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: chlorhexidine _based antisepsis; Including cases undergoing elective&non elective caesarean section.Patients will be were prepared similarly by three applications of 2%chlorhexidine solution time given between each application about 30 seconds followed by drying with a sterile towel and three applications of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision. .	Drug: Chlorhexidine
ACTIVE_COMPARATOR: povidone_iodine based antisepsis; Including cases undergoing elective&nonelective caesarean section.Patients will be scrubbed preoperative with an applicator that contain 10%povidone-iodine scrub aqueous solution(3 consecutive applications)followed by drying with sterile towel and 3 application of 70% alcohol after one minute The area scrubbed was from the xiphoid to the knee, reaching the midaxillary line laterally. In both groups, patients received preoperative prophylactic i.v antibiotics (cefotrixone 1 gm) one hour before skin incision	Drug: Povidone-Iodine; Other Names: Betadine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Surgical site infection within one week after surgery	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection within 30 days after surgery		in 30 days
Long hospital stay	hospital admission for more than 5 days	30 days
Hospital readmission	readmission due to sepsis	30 days
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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Director: AMR YEHIA, MD, MRCOG, Ain Shams Maternity Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2015
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: March 1, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (ESTIMATE): March 24, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Plasma Substitutes; Blood Substitutes; Chlorhexidine; Povidone-Iodine; Povidone
• Other Study ID Numbers: antisepsis 1