A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections

Phase 3TerminatedNCT00528008

Memorial University of Newfoundland268 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

268

Conditions

Wound Infection

Interventions

povidone-iodine solutionOTHER

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.

chlorhexidine gluconateOTHER

Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.

Eligibility

Sex: FEMALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Women' s Health Centre, Eastern Health

St. John's, Newfoundland and Labrador, Canada

Outcomes

Primary Outcomes

to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate