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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00528008
Other study ID # HIC07.33
Secondary ID
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


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
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