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STRIPES Study: Study To Reduce Infection Post cEsarean Section

NCT02402907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1356

Last updated 2020-11-09

Study results available
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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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Joanne Stone, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-10-11
Completion
2019-10-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02402907 on ClinicalTrials.gov