STRIPES Study: Study To Reduce Infection Post cEsarean Section

Surgical Site Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402907
• Other study ID #: GCO 14-1410
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: October 11, 2019

Study information

• Verified date: October 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1356
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women

• > 24 weeks gestation

• scheduled for a primary or repeat cesarean section

Exclusion criteria:

• allergy to chlorhexidine

• unplanned or emergency cesarean section

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Incisional SSI	Number of participants with Incisional Surgical Site Infection (SSI)	at 6 weeks
Primary	Number of Adherent Participants With Incisional SSI	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
Primary	Number of Participants With Endometritis	Number of participants with endometritis	at 6 weeks
Secondary	Number of Participants With Maternal Complications	Number of participants with maternal complications	up to 6 weeks
Secondary	Incidence of Neonatal ICU Admissions		up to 6 weeks
Secondary	Maternal Length of Stay	Length of stay (index hospitalization)	at 6 weeks
Secondary	Number of Participants With Maternal Readmissions	Number of participants with hospital readmission for wound complication	up to 6 weeks