N/A
N=1,404
Comparison of Surgical Skin Preps During Cesarean Deliveries
Surgical Site Infection Following Cesarean Delivery
Bottom Line
View on ClinicalTrials.gov: NCT01870583 ↗Enrolled (actual)
1,404
Serious AEs
0.5%
Results posted
Jun 2017
Primary outcome: Primary: Cesarean Surgical Site Infection — 18; 21; 21; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Iodine povidone (Drug); Chlorhexidine (Drug); Combination iodine and chlorhexidine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cesarean Surgical Site Infection |
18; 21; 21; 15; 15; 16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Gestational age > 37 weeks 0/7 days
- Non-emergency indication for cesarean
Exclusion Criteria
- Urogenital tract infection within 2 weeks prior to surgery
- Chronic oral or injectable steroid use (> 2 weeks)
- Emergency cesarean delivery
- Participation in another research study
Data sourced from ClinicalTrials.gov (NCT01870583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.