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Comparison of Surgical Skin Preps During Cesarean Deliveries

NCT01870583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1404

Last updated 2017-10-02

Study results available
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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.

Conditions

  • Surgical Site Infection Following Cesarean Delivery

Interventions

DRUG

Iodine povidone

Iodine skin preparation solution prior to cesarean delivery

DRUG

Chlorhexidine

Chlorhexidine skin preparation solution prior to cesarean delivery

DRUG

Combination iodine and chlorhexidine

Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • David A Wallach, CIP · Einstein IRB

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01870583 on ClinicalTrials.gov