N/A
N=1,356
STRIPES Study: Study To Reduce Infection Post cEsarean Section
Chlorhexidine Gluconate Cloths · Infection; Cesarean Section · Infectious Morbidity · Surgical Site Infections · Endometritis
Bottom Line
View on ClinicalTrials.gov: NCT02402907 ↗Enrolled (actual)
1,356
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Incisional SSI — 17; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 2% chlorhexidine gluconate (CHG) cloth (Device); Placebo cloth (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Incisional SSI |
17; 24 | — |
| PRIMARY Number of Adherent Participants With Incisional SSI |
10; 17 | — |
| PRIMARY Number of Participants With Endometritis |
0; 1 | — |
| SECONDARY Number of Participants With Maternal Complications |
16; 16; 19; 23; 21; 16 | — |
| SECONDARY Incidence of Neonatal ICU Admissions |
— | — |
| SECONDARY Maternal Length of Stay |
3.0; 3.0 | — |
| SECONDARY Number of Participants With Maternal Readmissions |
5; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02402907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.