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Comparison of Surgical Skin Preps During Cesarean Deliveries
N/A
Waitlist Available
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days after delivery
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Women are prospectively randomized to one of the three groups and followed until thier postpartum visit at 6-8 weeks following delivery.
Eligible Conditions
- Postpartum infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days after delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days after delivery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cesarean Surgical Site Infection
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: Combination iodine and chlorhexidineActive Control1 Intervention
The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.
Group II: ChlorhexidineActive Control1 Intervention
Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery
Group III: Iodine povidoneActive Control1 Intervention
Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
458 Previous Clinical Trials
587,210 Total Patients Enrolled
David A Wallach, CIPStudy ChairEinstein IRB