Clinical trial NCT02396329: Chlorhexidine Versus Povidone-Iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection
Official title: Chlorhexidine Versus Povidone-iodine Antisepsis for Reduction of Post Cesarean Section Surgical Site Infection Rate:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Surgical Site Infection
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 410
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
measure: Surgical site infection within one week after surgery
timeFrame: One week
Secondary outcomes:
measure: Surgical site infection within 30 days after surgery
timeFrame: in 30 days
measure: Long hospital stay
timeFrame: 30 days
measure: Hospital readmission
timeFrame: 30 days
measure: Febrile morbidity
timeFrame: 10 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: AMR YEHIA, MD, MRCOG
role: STUDY_DIRECTOR
References:
citation: 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.