STRIPES Study: Study To Reduce Infection Post cEsarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

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

Intervention / Treatment
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* Device: 2% chlorhexidine gluconate (CHG) cloth
* Device: Placebo cloth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women > 24 weeks gestation scheduled for a primary or repeat cesarean section Exclusion criteria: allergy to chlorhexidine unplanned or emergency cesarean section

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHG cloth<br>2% chlorhexidine gluconate (CHG) cloth | Device: 2% chlorhexidine gluconate (CHG) cloth<br>* 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.<br>* Other names: CHG;|
| Placebo Comparator: Placebo cloth<br>A fragrance free cleansing cloth | Device: Placebo cloth<br>* 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.<br>* Other names: Cleansing cloth;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, chlorhexidine gluconate, CHG, surgical site infection, obstetrics, infection prevention, pregnancy