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Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor

NCT03423147 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2023-03-23

Study results available
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Summary

Surgical site infections (SSI) are the second most common cause of nosocomial infections accounting for 15% of all nosocomial infections among hospitalized patients and 38% of nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor.

Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria, reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI.

Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is limited. This study intends to evaluate the effectiveness of use of both chlorhexidine gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean section that have previously been laboring. Patients will be randomized to one of two groups: wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal scrub in addition to standard preoperative scrub as compared to standard preoperative scrub alone.

Conditions

  • Cesarean Section
  • Surgical Site Infection
  • Nosocomial Infection

Interventions

DRUG

2% chlorhexidine gluconate cloth

applied to their abdomen

DRUG

4% Chlorhexidine gluconate vaginal scrub

applied as a vaginal cleanse in the operating room prior to cesarean section

Sponsors & Collaborators

  • Stryker Nordic

    collaborator INDUSTRY

  • Angela Bianco

    lead OTHER

Principal Investigators

  • Angela Bianco, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-05
Primary Completion
2021-02-11
Completion
2021-02-11
FDA Drug
Yes

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 NCT03423147 on ClinicalTrials.gov