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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00528008
Recruitment Status : Terminated (Study was stopped following interim analysis.)
First Posted : September 11, 2007
Last Update Posted : November 9, 2012
Eastern Health
Information provided by (Responsible Party):
Memorial University of Newfoundland

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.

Condition or disease Intervention/treatment Phase
Wound Infection Other: povidone-iodine solution Other: chlorhexidine gluconate Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
Study Start Date : December 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Active Comparator: A
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 Name: Betadine, Povidone, Minidyne

Active Comparator: B
chlorhexidine gluconate
Other: chlorhexidine gluconate
Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.
Other Name: Dexidine, Avagard, Bactoshield

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. readmission to hospital [ Time Frame: within 6 weeks following surgery ]
  2. extended length of admission [ Time Frame: within 6 weeks following surgery ]
  3. need for intravenous antibiotics [ Time Frame: within 6 weeks following surgery ]
  4. need for repeat procedure such as drainage [ Time Frame: within 6 weeks following surgery ]
  5. increased outpatient surveillance [ Time Frame: within 6 weeks following surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00528008

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Canada, Newfoundland and Labrador
Women' s Health Centre, Eastern Health
St. John's, Newfoundland and Labrador, Canada, A1E 5K9
Sponsors and Collaborators
Memorial University of Newfoundland
Eastern Health
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Principal Investigator: Paula Mallaley, MD Resident, Obstetrics and Gynecology, Memorial University of Newfoundland
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Responsible Party: Memorial University of Newfoundland Identifier: NCT00528008    
Other Study ID Numbers: HIC07.33
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012
Keywords provided by Memorial University of Newfoundland:
chlorhexidine gluconate
vaginal discharge
elective cesarean section
Additional relevant MeSH terms:
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Communicable Diseases
Wound Infection
Wounds and Injuries
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Plasma Substitutes
Blood Substitutes