Wound Infection Clinical Trial
Official title:
Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Women' s Health Centre, Eastern Health | St. John's | Newfoundland and Labrador |
Lead Sponsor | Collaborator |
---|---|
Memorial University of Newfoundland | Eastern Health |
Canada,
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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