Skip to main content
OpenTrials
Completed

NCT Number: NCT02402907

STRIPES Study: Study To Reduce Infection Post cEsarean Section

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • allergy to chlorhexidine
  • unplanned or emergency cesarean section

Treatment and study plan

2% chlorhexidine gluconate (CHG) cloth

Device

administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.

Other names: CHG

Placebo cloth

Device

administration of a cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.

Other names: Cleansing cloth

Primary outcomes

  1. Number of Participants With Incisional SSI

    Time frame: at 6 weeks

    Number of participants with Incisional Surgical Site Infection (SSI)

  2. 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.

  3. Number of Participants With Endometritis

    Time frame: at 6 weeks

    Number of participants with endometritis

Secondary outcomes

  1. Number of Participants With Maternal Complications

    Time frame: up to 6 weeks

    Number of participants with maternal complications

  2. Incidence of Neonatal ICU Admissions

    Time frame: up to 6 weeks

  3. Maternal Length of Stay

    Time frame: at 6 weeks

    Length of stay (index hospitalization)

  4. Number of Participants With Maternal Readmissions

    Time frame: up to 6 weeks

    Number of participants with hospital readmission for wound complication

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2015
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.