Clinical trial NCT02402907: STRIPES Study: Study To Reduce Infection Post cEsarean Section
Official title: A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Cloth Reduces Infectious Morbidity in Patients Undergoing Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlorhexidine Gluconate Cloths
Infection; Cesarean Section
Infectious Morbidity
Surgical Site Infections
Endometritis
Keywords: cesarean section
chlorhexidine gluconate
CHG
surgical site infection
obstetrics
infection prevention
pregnancy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 1356
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion criteria:

* allergy to chlorhexidine
* unplanned or emergency cesarean section

Primary outcomes:
measure: Number of Participants With Incisional SSI
timeFrame: at 6 weeks
measure: Number of Adherent Participants With Incisional SSI
timeFrame: at 6 weeks
measure: Number of Participants With Endometritis
timeFrame: at 6 weeks
Secondary outcomes:
measure: Number of Participants With Maternal Complications
timeFrame: up to 6 weeks
measure: Incidence of Neonatal ICU Admissions
timeFrame: up to 6 weeks
measure: Maternal Length of Stay
timeFrame: at 6 weeks
measure: Number of Participants With Maternal Readmissions
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Joanne Stone, MD
role: PRINCIPAL_INVESTIGATOR
References: