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

Primary Purpose

Cesarean Section, Surgical Site Infection, Nosocomial Infection

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
2% chlorhexidine gluconate cloth
4% Chlorhexidine gluconate vaginal scrub
Sponsored by
Angela Bianco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section focused on measuring Cesarean section, Labor, Surgical Site Infections, Chlorhexidine gluconate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chlorhexidine gluconate vaginal scrub and cloth

Standard Treatment

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of Participants With Surgical Site Infection
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

Number of Participants With Maternal Complications or Interventions
Number of Participants With Neonatal ICU Admissions
Number of participants with newborn with neonatal ICU admissions
Maternal Length of Stay
Number of Participants With Readmissions
Estimated Blood Loss
Length of Time From Incision to Delivery
Length of Operation

Full Information

First Posted
January 31, 2018
Last Updated
February 23, 2023
Sponsor
Angela Bianco
Collaborators
Stryker Nordic
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1. Study Identification

Unique Protocol Identification Number
NCT03423147
Brief Title
Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor
Acronym
PRACTICAL
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment, inability to achieve required number of subjects
Study Start Date
October 5, 2018 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Angela Bianco
Collaborators
Stryker Nordic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Surgical Site Infection, Nosocomial Infection
Keywords
Cesarean section, Labor, Surgical Site Infections, Chlorhexidine gluconate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine gluconate vaginal scrub and cloth
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
2% chlorhexidine gluconate cloth
Other Intervention Name(s)
2% Chloraprep solution
Intervention Description
applied to their abdomen
Intervention Type
Drug
Intervention Name(s)
4% Chlorhexidine gluconate vaginal scrub
Intervention Description
applied as a vaginal cleanse in the operating room prior to cesarean section
Primary Outcome Measure Information:
Title
Number of Participants With Surgical Site Infection
Description
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.
Time Frame
up to 6 weeks postpartum
Secondary Outcome Measure Information:
Title
Number of Participants With Maternal Complications or Interventions
Time Frame
up to 6 weeks postpartum
Title
Number of Participants With Neonatal ICU Admissions
Description
Number of participants with newborn with neonatal ICU admissions
Time Frame
up to 6 weeks postpartum
Title
Maternal Length of Stay
Time Frame
up to 6 weeks postpartum
Title
Number of Participants With Readmissions
Time Frame
up to 6 weeks postpartum
Title
Estimated Blood Loss
Time Frame
Day 1
Title
Length of Time From Incision to Delivery
Time Frame
Day 1
Title
Length of Operation
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Bianco, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27583685
Citation
Ahmed MR, Aref NK, Sayed Ahmed WA, Arain FR. Chlorhexidine vaginal wipes prior to elective cesarean section: does it reduce infectious morbidity? A randomized trial. J Matern Fetal Neonatal Med. 2017 Jun;30(12):1484-1487. doi: 10.1080/14767058.2016.1219996. Epub 2016 Sep 1.
Results Reference
background
PubMed Identifier
28796683
Citation
Caissutti C, Saccone G, Zullo F, Quist-Nelson J, Felder L, Ciardulli A, Berghella V. Vaginal Cleansing Before Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Sep;130(3):527-538. doi: 10.1097/AOG.0000000000002167.
Results Reference
background
PubMed Identifier
15695981
Citation
Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010.
Results Reference
background
PubMed Identifier
20054046
Citation
Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
Results Reference
background
PubMed Identifier
32580252
Citation
Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5.
Results Reference
derived
PubMed Identifier
32335895
Citation
Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Results Reference
derived

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

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