ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
Stryker Nordic
Information provided by (Responsible Party):
Angela Bianco, Icahn School of Medicine at Mount Sinai

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.


Condition or disease Intervention/treatment Phase
Cesarean Section Surgical Site Infection Drug: 2% chlorhexidine gluconate cloth Drug: 4% Chlorhexidine gluconate vaginal scrub Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
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
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

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.
Drug: 2% chlorhexidine gluconate cloth
applied to their abdomen
Other Name: 2% Chloraprep solution




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of maternal complications or interventions [ Time Frame: up to 6 weeks postpartum ]
  2. Number of neonatal ICU admissions [ Time Frame: up to 6 weeks postpartum ]
  3. Maternal length of stay [ Time Frame: up to 6 weeks postpartum ]
  4. Number of readmissions [ Time Frame: up to 6 weeks postpartum ]
  5. Estimated blood loss [ Time Frame: Day 1 ]
  6. Length of time from incision to delivery [ Time Frame: Day 1 ]
  7. Length of operation [ Time Frame: Day 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423147


Contacts
Contact: Angela Bianco, MD 212-241-6840 angela.bianco@mssm.edu
Contact: Patricia Rekawek, MD 212-241-3386 patricia.rekawek@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Principal Investigator: Angela Bianco, MD         
Sponsors and Collaborators
Angela Bianco
Stryker Nordic
Investigators
Principal Investigator: Angela Bianco, MD Icahn School of Medicine at Mount Sinai

Publications:
Responsible Party: Angela Bianco, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03423147     History of Changes
Other Study ID Numbers: GCO 17-1235
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Angela Bianco, Icahn School of Medicine at Mount Sinai:
Cesarean section
Labor
Surgical Site Infections
Chlorhexidine gluconate

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents