Trial | NCT00528008  Report issue

Title

A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    268
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 Started
Dec 31
2007
Primary Completion
Feb 28
2010
Study Completion
Feb 28
2010
Last Update
Nov 09
2012
Estimate

Other povidone-iodine solution

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.

  • Other names: Betadine, Povidone, Minidyne

Other chlorhexidine gluconate

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

  • Other names: Dexidine, Avagard, Bactoshield

A Active Comparator

povidone-iodine

B Active Comparator

chlorhexidine gluconate

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
No Results Posted