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Clinical Trials/NCT02402907
NCT02402907CompletedNot Applicable

A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Cloth Reduces Infectious Morbidity in Patients Undergoing Cesarean Section

Icahn School of Medicine at Mount Sinai1 site in 1 country1,356 target enrollmentStarted: April 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,356
Locations
1
Primary Endpoint
Number of Participants With Incisional SSI

Study Overview

Brief Summary

The objective of this study is to determine if the use of chlorhexidine gluconate cloths prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site infections, endometritis).

The study will be offered to women who present for a scheduled primary or repeat cesarean section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned. This study intends to show that the use of 2% CHG cloths prior to cesarean section will reduce the rate of surgical site infections.

Detailed Description

Chlorhexidine is a sterile, germ-free solution, which is regularly used to clean the skin immediately before surgery and works by killing or preventing the growth or spread of bacteria. Data exists in both the orthopedic and cardiac literature to show that an additional preoperative use of chlorhexidine further reduces the risk of post procedure infections. Limited data exists regarding the use of a preoperative use of chlorhexidine in patients undergoing Obstetric or Gynecologic procedures and there is no wash or cloth used prior to cesarean section as a standard of care. The hope for this study is to identify if an additional preoperative chlorhexidine wash will further decrease or prevent infection in women who deliver their babies via cesarean section.

All patients with a scheduled cesarean section surgery will be approached for enrollment during their pre-admission testing visit on the labor floor 2 days before the scheduled cesarean section, a visit that is standard procedure for this surgery. Once a patient is consented, she will be randomly assigned to one of the 2 arms of the study: the eligible women will be randomized to use of 2% chlorhexidine gluconate (CHG) cloths or placebo cloths (a fragrance free cleansing cloths) on the body the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned.

The purpose of this study is to determine if the use of 2% chlorhexidine gluconate cloths prior to cesarean section reduces the rate of surgical site wound infection and/or postpartum endometritis, which is an infection or inflammation of the endometrium (the inner lining of the uterus).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •> 24 weeks gestation
  • •scheduled for a primary or repeat cesarean section

Exclusion Criteria

  • •allergy to chlorhexidine
  • •unplanned or emergency cesarean section

Arms & Interventions

CHG cloth

Experimental

2% chlorhexidine gluconate (CHG) cloth

Intervention: 2% chlorhexidine gluconate (CHG) cloth (Device)

Placebo cloth

Placebo Comparator

A fragrance free cleansing cloth

Intervention: Placebo cloth (Device)

Outcomes

Primary Outcomes

Number of Participants With Incisional SSI

Time Frame: at 6 weeks

Number of participants with Incisional Surgical Site Infection (SSI)

Number of Participants With Endometritis

Time Frame: at 6 weeks

Number of participants with endometritis

Number of Adherent Participants With Incisional SSI

Time Frame: at 6 weeks

Among those with full adherence to the protocol and who were available for assessment at 6 weeks. Adherence to the protocol was assessed in the following 2 ways: evaluation of returned packages on the day of surgery and report ascertained by phone interview at 2 weeks.

Secondary Outcomes

  • Maternal Length of Stay(at 6 weeks)
  • Incidence of Neonatal ICU Admissions(up to 6 weeks)
  • Number of Participants With Maternal Complications(up to 6 weeks)
  • Number of Participants With Maternal Readmissions(up to 6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joanne L Stone

Professor

Icahn School of Medicine at Mount Sinai

Study Sites (1)

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