STRIPES Study: Study To Reduce Infection Post cEsarean Section

October 16, 2020 updated by: Joanne L Stone, Icahn School of Medicine at Mount Sinai

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

1356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion criteria:

  • allergy to chlorhexidine
  • unplanned or emergency cesarean section

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHG cloth
2% chlorhexidine gluconate (CHG) cloth
Device: 2% chlorhexidine gluconate (CHG) cloth
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 Comparator: Placebo cloth
A fragrance free cleansing cloth
Device: Placebo cloth
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Incisional SSI
Time Frame: at 6 weeks
Number of participants with Incisional Surgical Site Infection (SSI)
at 6 weeks
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.
at 6 weeks
Number of Participants With Endometritis
Time Frame: at 6 weeks
Number of participants with endometritis
at 6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Joanne Stone, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

October 11, 2019

Study Completion (Actual)

October 11, 2019

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

November 9, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 14-1410

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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