NCT03423147

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

A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Gluconate Cloth and Chlorhexidine Gluconate Vaginal Scrub Reduces Infectious Morbidity in Patients Undergoing Cesarean Section After Labor

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Angela Bianco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be offered to women who are admitted to undergo labor at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth with 4% chlorhexidine gluconate vaginal scrub (including standard preoperative care prior to cesarean section) or standard preoperative care. Participants will not be blinded to the arm in which they have been assigned. Researchers will have access to all patients scheduled for delivery at Mount Sinai Medical Center. About 1800 deliveries by cesarean section occur each year at Mount Sinai. Of these, approximately 800 are cesarean sections after failed labor. Assuming a primary outcome rate of 20% in the control arm, a sample size of 329 in each group would give 80% power to detect a 40% reduction in surgical site infection between the active group and control. The aim is to recruit 400 patients per group (for a total of 800 patients) to account for patient drop out or non-compliance. Sage Products, Inc will be providing the CHG cloths. This study intends to show that simultaneous use of 2% CHG cloths and 4% CHG vaginal scrub prior to cesarean section will reduce the rate of SSI in women who have previously been laboring.

Conditions

• Cesarean Section
• Surgical Site Infection
• Nosocomial Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-05
• Primary completion: 2021-02-11
• Completion: 2021-02-11
• First posted: 2018-02-06
• Last updated: 2023-03-23
• Results posted: 2023-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study