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

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.

Full Title of Study: “Povidone-iodine vs. Chlorhexidine Gluconate – A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2010

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

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

Arms, Groups and Cohorts

  • Active Comparator: A
    • povidone-iodine
  • Active Comparator: B
    • chlorhexidine gluconate

Clinical Trial Outcome Measures

Primary Measures

  • to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate
    • Time Frame: within 6 weeks following surgery

Secondary Measures

  • readmission to hospital
    • Time Frame: within 6 weeks following surgery
  • extended length of admission
    • Time Frame: within 6 weeks following surgery
  • need for intravenous antibiotics
    • Time Frame: within 6 weeks following surgery
  • need for repeat procedure such as drainage
    • Time Frame: within 6 weeks following surgery
  • increased outpatient surveillance
    • Time Frame: within 6 weeks following surgery

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Memorial University of Newfoundland
  • Collaborator
    • Eastern Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paula Mallaley, MD, Principal Investigator, Resident, Obstetrics and Gynecology, Memorial University of Newfoundland

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