STRIPES Study: Study To Reduce Infection Post cEsarean Section

Mount Sinai Health System

Status: Completed

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

Treatments: Device: Placebo cloth; Device: 2% chlorhexidine gluconate (CHG) cloth

Study type: Interventional

Funder types: Other

Identifiers

NCT02402907

GCO 14-1410

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,356 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• allergy to chlorhexidine
• unplanned or emergency cesarean section

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,356 participants in 2 patient groups, including a placebo group

CHG cloth

Experimental group

Description:

2% chlorhexidine gluconate (CHG) cloth

Treatment:

Device: 2% chlorhexidine gluconate (CHG) cloth

Placebo cloth

Placebo Comparator group

Description:

A fragrance free cleansing cloth

Treatment:

Device: Placebo cloth