A Randomized Trial to Determine if a Pre-Operative Wash with a Chlorhexidine Cloth Reduces Infectious Morbidity in Patients Undergoing Cesarean Section
ID Number 14-1410Principal Investigator(s)
Department(s) or Division(s)
Obstetrics, Gynecology, and Reproductive Science
The purpose of this study, also known as The Stripes Trial (Study to Reduce Infection Post cEsarean Section), is to determine if the use of 2% chlorhexidine gluconate cloths prior to scheduled 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).
Patients who qualify to take part in this research study are pregnant and are scheduled for a cesarean section at Mount Sinai Medical Center.
Study participants are randomized to self-administer a 2% chlorhexidine gluconate cloth wash or a standard cleansing cloth wash on the night before (at home) and the morning of the scheduled cesarean section. Neither the patient nor the study team will know which study treatment participants receive. This information could be obtained in an emergency, however. All current standards of care for cesarean section delivery will be provided.
Chlorhexidine gluconate cloths as well as the placebo, a standard cleansing cloth, are provided by Sage Products Inc, a healthcare product manufacturing company. Any additional funds for conducting this research are provided by Icahn School of Medicine at Mount Sinai.
Recruiting Patients: Yes