Clinical trial NCT00528008: A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
Official title: Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Wound Infection
Keywords: infection
sepsis
povidone-iodine
chlorhexidine gluconate
fever
erythema
leukocytosis
drainage
vaginal discharge
elective cesarean section
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
Collaborators: name: Eastern Health
First posted: 2007-09-11
Enrollment: 268
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate
timeFrame: within 6 weeks following surgery
Secondary outcomes:
measure: readmission to hospital
timeFrame: within 6 weeks following surgery
measure: extended length of admission
timeFrame: within 6 weeks following surgery
measure: need for intravenous antibiotics
timeFrame: within 6 weeks following surgery
measure: need for repeat procedure such as drainage
timeFrame: within 6 weeks following surgery
measure: increased outpatient surveillance
timeFrame: within 6 weeks following surgery
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Women' s Health Centre, Eastern Health
state: Newfoundland and Labrador
Study officials:
affiliation: Resident, Obstetrics and Gynecology, Memorial University of Newfoundland
name: Paula Mallaley, MD
role: PRINCIPAL_INVESTIGATOR
References: