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

Phase 3

Terminated

• Conditions: Wound Infection
• Interventions: Other: povidone-iodine solution; Other: chlorhexidine gluconate

• Registration Number: NCT00528008
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2007-09-10
• Study First Submitted QC: 2007-09-10
• Study First Posted: 2007-09-11
• Study Start: 2007-12
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	povidone-iodine solution	povidone-iodine
B	chlorhexidine gluconate	chlorhexidine gluconate

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Women' s Health Centre, Eastern Health; 🇨🇦 St. John's, Newfoundland and Labrador, Canada