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Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor (PRACTICAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03423147
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Stryker Nordic
Information provided by (Responsible Party):
Angela Bianco, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE January 31, 2018
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE October 5, 2018
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
Rate of surgical site infection [ Time Frame: up to 6 weeks postpartum ]
Surgical site infection will be a composite of wound infection and postpartum endometritis. Endometritis is defined as postoperative fever of 100.4 °F or more occurring 24 hours after delivery associated with uterine tenderness and persistent foul-smelling lochia, requiring broad-spectrum intravenous antibiotic administration. Wound infection is defined as erythema or wound edge separation with purulent discharge involving the cesarean incision site that requires antibiotic therapy and wound care.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03423147 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • Number of maternal complications or interventions [ Time Frame: up to 6 weeks postpartum ]
  • Number of neonatal ICU admissions [ Time Frame: up to 6 weeks postpartum ]
  • Maternal length of stay [ Time Frame: up to 6 weeks postpartum ]
  • Number of readmissions [ Time Frame: up to 6 weeks postpartum ]
  • Estimated blood loss [ Time Frame: Day 1 ]
  • Length of time from incision to delivery [ Time Frame: Day 1 ]
  • Length of operation [ Time Frame: Day 1 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor
Official Title  ICMJE A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Gluconate Cloth and Chlorhexidine Gluconate Vaginal Scrub Reduces Infectious Morbidity in Patients Undergoing Cesarean Section After Labor
Brief Summary

Surgical site infections (SSI) are the second most common cause of nosocomial infections accounting for 15% of all nosocomial infections among hospitalized patients and 38% of nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor.

Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria, reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI.

Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is limited. This study intends to evaluate the effectiveness of use of both chlorhexidine gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean section that have previously been laboring. Patients will be randomized to one of two groups: wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal scrub in addition to standard preoperative scrub as compared to standard preoperative scrub alone.

Detailed Description

The study will be offered to women who are admitted to undergo labor at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth with 4% chlorhexidine gluconate vaginal scrub (including standard preoperative care prior to cesarean section) or standard preoperative care. Participants will not be blinded to the arm in which they have been assigned.

Researchers will have access to all patients scheduled for delivery at Mount Sinai Medical Center. About 1800 deliveries by cesarean section occur each year at Mount Sinai. Of these, approximately 800 are cesarean sections after failed labor. Assuming a primary outcome rate of 20% in the control arm, a sample size of 329 in each group would give 80% power to detect a 40% reduction in surgical site infection between the active group and control. The aim is to recruit 400 patients per group (for a total of 800 patients) to account for patient drop out or non-compliance.

Sage Products, Inc will be providing the CHG cloths.

This study intends to show that simultaneous use of 2% CHG cloths and 4% CHG vaginal scrub prior to cesarean section will reduce the rate of SSI in women who have previously been laboring.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cesarean Section
  • Surgical Site Infection
Intervention  ICMJE
  • Drug: 2% chlorhexidine gluconate cloth
    applied to their abdomen
    Other Name: 2% Chloraprep solution
  • Drug: 4% Chlorhexidine gluconate vaginal scrub
    applied as a vaginal cleanse in the operating room prior to cesarean section
Study Arms  ICMJE
  • Experimental: Chlorhexidine gluconate vaginal scrub and cloth
    Patients will have a 2% chlorhexidine gluconate cloth applied to their abdomen as well as 4% chlorhexidine gluconate vaginal scrub applied as a vaginal cleanse in the operating room prior to cesarean section
    Interventions:
    • Drug: 2% chlorhexidine gluconate cloth
    • Drug: 4% Chlorhexidine gluconate vaginal scrub
  • Active Comparator: Standard Treatment
    Patients who are not in the intervention arm will receive the standard of care prior to a cesarean section. In the operating room the patient will receive an abdominal cleanse with 2% Chloraprep solution (2% chlorhexidine gluconate) in addition to routine IV antibiotics.
    Intervention: Drug: 2% chlorhexidine gluconate cloth
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2018)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women at > 24 weeks gestation who are admitted in labor or admitted for induction of labor at Mount Sinai Hospital

Exclusion Criteria:

  • allergy to chlorhexidine
  • unplanned or emergency cesarean section
  • women at <24 weeks gestation
  • estimated fetal weight <500 grams
  • fetal face presentation regardless of gestational age.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angela Bianco, MD 212-241-6840 angela.bianco@mssm.edu
Contact: Patricia Rekawek, MD 212-241-3386 patricia.rekawek@mssm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03423147
Other Study ID Numbers  ICMJE GCO 17-1235
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angela Bianco, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Angela Bianco
Collaborators  ICMJE Stryker Nordic
Investigators  ICMJE
Principal Investigator: Angela Bianco, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP