STRIPES Study: Study To Reduce Infection Post cEsarean Section

Not Applicable

Completed

Conditions: Chlorhexidine Gluconate Cloths
Endometritis
Infectious Morbidity
Surgical Site Infections
Infection; Cesarean Section

Interventions: Device: 2% chlorhexidine gluconate (CHG) cloth
Device: Placebo cloth

Registration Number: NCT02402907

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1356

Inclusion Criteria

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

Exclusion criteria:

allergy to chlorhexidine
unplanned or emergency cesarean section

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHG cloth	2% chlorhexidine gluconate (CHG) cloth	2% chlorhexidine gluconate (CHG) cloth
Placebo cloth	Placebo cloth	A fragrance free cleansing cloth

Primary Outcome Measures

Name	Time	Method
Number of Participants With Incisional SSI	at 6 weeks	Number of participants with Incisional Surgical Site Infection (SSI)
Number of Participants With Endometritis	at 6 weeks	Number of participants with endometritis
Number of Adherent Participants With Incisional SSI	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 Outcome Measures

Name	Time	Method
Maternal Length of Stay	at 6 weeks	Length of stay (index hospitalization)
Incidence of Neonatal ICU Admissions	up to 6 weeks
Number of Participants With Maternal Complications	up to 6 weeks	Number of participants with maternal complications
Number of Participants With Maternal Readmissions	up to 6 weeks	Number of participants with hospital readmission for wound complication