CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,356 enrolled
Drug / intervention
2% chlorhexidine gluconate (CHG) cloth +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02402907
NCT02402907N/ACompleted

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

Icahn School of Medicine at Mount Sinai·interventional·Posted Mar 30, 2015·Updated Nov 9, 2020

In Brief

A clinical study evaluating 2% chlorhexidine gluconate (CHG) cloth and Placebo cloth for Chlorhexidine Gluconate Cloths and 4 related conditions. Completed, enrolled 1,356 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 30, 2015
Enrollment StartApr 1, 2015
Primary CompletionOct 11, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.3 years ago

Interventions

2% chlorhexidine gluconate (CHG) clothdevice

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.

Placebo clothdevice

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.