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

This study has been terminated.
(Study was stopped following interim analysis.)
Sponsor:
Collaborator:
Eastern Health
Information provided by (Responsible Party):
Memorial University of Newfoundland
ClinicalTrials.gov Identifier:
NCT00528008
First received: September 10, 2007
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Wound Infection
Other: povidone-iodine solution
Other: chlorhexidine gluconate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial University of Newfoundland:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • readmission to hospital [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]
  • extended length of admission [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]
  • need for intravenous antibiotics [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]
  • need for repeat procedure such as drainage [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]
  • increased outpatient surveillance [ Time Frame: within 6 weeks following surgery ] [ Designated as safety issue: No ]

Enrollment: 268
Study Start Date: December 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
povidone-iodine
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

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528008

Locations
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
Investigators
Principal Investigator: Paula Mallaley, MD Resident, Obstetrics and Gynecology, Memorial University of Newfoundland
  More Information

No publications provided

Responsible Party: Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT00528008     History of Changes
Other Study ID Numbers: HIC07.33
Study First Received: September 10, 2007
Last Updated: November 8, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Memorial University of Newfoundland:
infection
sepsis
povidone-iodine
chlorhexidine gluconate
fever
erythema
leukocytosis
drainage
vaginal discharge
elective cesarean section

Additional relevant MeSH terms:
Wound Infection
Infection
Wounds and Injuries
Povidone
Chlorhexidine
Chlorhexidine gluconate
Iodine
Cadexomer iodine
Povidone-Iodine
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014