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

• Status: Terminated
• Trial end date: 2021-02-11
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Angela Bianco
• Collaborator: Stryker Nordic
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

• Women at > 24 weeks gestation who are admitted in labor or admitted for induction of labor at Mount Sinai Hospital

Exclusion Criteria:

• Allergy to chlorhexidine

• Unplanned or emergency cesarean section

• Women at <24 weeks gestation

• Estimated fetal weight <500 grams

• Fetal face presentation regardless of gestational age.