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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wound Infection

Intervention / Treatment
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* Other: povidone-iodine solution
* Other: chlorhexidine gluconate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>povidone-iodine | Other: povidone-iodine solution<br>* 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.<br>* Other names: Betadine, Povidone, Minidyne;|
| Active Comparator: B<br>chlorhexidine gluconate | Other: chlorhexidine gluconate<br>* Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.<br>* Other names: Dexidine, Avagard, Bactoshield;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, sepsis, povidone-iodine, chlorhexidine gluconate, fever, erythema, leukocytosis, drainage, vaginal discharge, elective cesarean section