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N/A N=932 Randomized Treatment

Chlorhexidine-Alcohol Versus Povidone-Iodine for Cesarean Antisepsis

Surgical Site Infection

Enrolled (actual)
932
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Number of Patients With Surgical Site Infection — 29; 33 Participants — p=0.38

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Chlorhexidine - Isopropyl alcohol (Drug); Povidone-Iodine Scrub and Paint (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Case Western Reserve University
Primary completion
Jul 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Surgical Site Infection
29; 33 0.38
SECONDARY
Number of Patients With Non-infections Surgical Site Complications
19; 17

Summary

Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.

Eligibility Criteria

Inclusion Criteria

  • cesarean delivery
  • age 18-65
  • ability to consent in English or Spanish

Exclusion Criteria

  • inability or unwillingness to consent to study participation in English or Spanish
  • current incarceration
  • pre-operative diagnosis of chorioamnionitis
  • perceived inability to complete follow up for data collection
  • any prior known allergy or adverse reaction to either study preparation
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02202577). 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.

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