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

Wound Infection Clinical Trial

Official title:

Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00528008
• Other study ID #: HIC07.33
• Status: Terminated
• Phase: Phase 3
• First received: September 10, 2007
• Last updated: November 8, 2012
• Start date: December 2007
• Est. completion date: February 2010

Study information

• Verified date: November 2012
• Source: Memorial University of Newfoundland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 268
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Wound Infection

Intervention

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

Locations

Country	Name	City	State
Canada	Women' s Health Centre, Eastern Health	St. John's	Newfoundland and Labrador

Sponsors (2)

Lead Sponsor	Collaborator
Memorial University of Newfoundland	Eastern Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate		within 6 weeks following surgery	No
Secondary	readmission to hospital		within 6 weeks following surgery	No
Secondary	extended length of admission		within 6 weeks following surgery	No
Secondary	need for intravenous antibiotics		within 6 weeks following surgery	No
Secondary	need for repeat procedure such as drainage		within 6 weeks following surgery	No
Secondary	increased outpatient surveillance		within 6 weeks following surgery	No