Wound Infection
Conditions
Keywords
infection, sepsis, povidone-iodine, chlorhexidine gluconate, fever, erythema, leukocytosis, drainage, vaginal discharge, elective cesarean section
Brief summary
The purpose of this study is to find out if chlorhexidine gluconate solution is better at reducing the rate of wound infection after cesarean section compared to povidone-iodine.
Detailed description
Wound infection is a universal potential morbidity to any type of surgery. Over the years many studies have been completed to evaluate ways to decrease this morbidity. Recent literature has looked at different types of surgical solutions used in pre-operative cleansing. Chlorhexidine and povidone-iodine are two standard surgical prep solutions used on a global scale. The most recent literature has shown that chlorhexidine has a decreased wound infection rate for longer surgeries. Cesarean section, as a surgical time, varies from 20 - 60 minutes. There has been no known literature regarding wound infection rates using these two solutions in elective cesarean sections. This trial will review the rates of wound infection using chlorhexidine and povidone-iodine during elective cesarean section and determine if there is any statistically significant difference between the two solutions. The results could potentially decrease wound infection rates, decrease morbidity, decrease hospital length of stay, and help to guide further surgical management.
Interventions
Abdominal surgical field cleaned with 5% povidone-iodine detergent scrub, detergent cleaned from surgical area with sterile water, and then painted with 1% povidone-iodine solution.
OTHERchlorhexidine gluconate
Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.
Sponsors
Eastern Health
Memorial University of Newfoundland
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \>19 years * Gestational age \> 37 weeks * Booked elective cesarean section
Exclusion criteria
* Gestational age \< 37 weeks * Premature rupture of membranes * Onset of labor prior to procedure * Evidence of maternal sepsis; maternal fever \> 38.5C * LSCS for emergency issues: non-reassuring fetal status, placental abruption, failed induction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate | within 6 weeks following surgery |
Secondary
| Measure | Time frame |
|---|---|
| readmission to hospital | within 6 weeks following surgery |
| extended length of admission | within 6 weeks following surgery |
| need for intravenous antibiotics | within 6 weeks following surgery |
| need for repeat procedure such as drainage | within 6 weeks following surgery |
| increased outpatient surveillance | within 6 weeks following surgery |
Countries
Canada
Outcome results
None listed