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

M

Memorial University of Newfoundland

Status and phase

Terminated
Phase 3

Conditions

Wound Infection

Treatments

Other: chlorhexidine gluconate
Other: povidone-iodine solution

Study type

Interventional

Funder types

Other

Identifiers

NCT00528008
HIC07.33

Details and patient eligibility

About

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 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.

Enrollment

268 patients

Sex

Female

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

268 participants in 2 patient groups

A
Active Comparator group
Description:
povidone-iodine
Treatment:
Other: povidone-iodine solution
B
Active Comparator group
Description:
chlorhexidine gluconate
Treatment:
Other: chlorhexidine gluconate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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