Surgical Site Infection
Conditions
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.
Interventions
DRUGPovidone-Iodine
DRUGChlorhexidine
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical site infection within one week after surgery | One week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection within 30 days after surgery | in 30 days | — |
| Long hospital stay | 30 days | hospital admission for more than 5 days |
| Hospital readmission | 30 days | readmission due to sepsis |
| Febrile morbidity | 10 days | 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 |
Countries
Egypt
Contacts
Primary ContactAMR YEHIA, MD, MRCOG
Outcome results
None listed