Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries
Primary Purpose
Surgical Site Infection
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine Cloth
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring Chlorhexidine Cloth, Surgical Site Infection, Non-scheduled cesarean delivery
Eligibility Criteria
Inclusion Criteria:
- undergoing non-scheduled cesarean delivery > 23 weeks gestation
Exclusion Criteria:
- allergy to chlorhexidine, emergency cesarean delivery, evidence of infection at operative site
Sites / Locations
- North Shore University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Chlorhexidine Cloth
Standard Preoperative Care
Arm Description
The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths.
The no intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care.
Outcomes
Primary Outcome Measures
Rate of surgical site infection
Secondary Outcome Measures
Hospital length of stay
Number of office visits
Number of hospital readmissions for infection-related complications
Rate of endometritis
Rate of positive wound culture from wound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04202471
Brief Title
Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries
Official Title
Preoperative Chlorhexidine Cloths to Reduce Surgical Site Infection in Non-Scheduled Cesarean Deliveries
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
COVID-19 pandemic
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Pregnancy-associated infection represents a major cause of maternal morbidity and mortality. Cesarean delivery is the most common major surgical procedure and is associated with a rate of surgical site infection (SSI) that is approximately 5-10 times the rate for vaginal delivery. Efforts to reduce the risk of SSIs in this patient population include the use of preoperative antibiotic prophylaxis in addition to skin and vaginal antiseptic preparations.Nevertheless, the rate of SSI in women undergoing non-scheduled cesarean delivery is up to 18%, a significant number that contributes to prolonged hospital stays and increased health care costs.
Every effort should be made to reduce this major cause of pregnancy-associated morbidity and mortality to aid in the care of patients and reduce the associated prolonged hospital stays, readmission rates and health care costs. Studies have shown that preoperative application of chlorhexidine cloths reduces the risk of SSI, however this is based on literature in the orthopedic and intensive care patients. The efficacy of this intervention has not been studied in obstetric patients undergoing cesarean delivery. Furthermore, obstetric patients undergoing non-scheduled cesarean delivery represent a target population as it is thought that infectious morbidity is higher in this patient population. Therefore, there is a need for this trial to determine if this intervention is effective in reducing the rate of postoperative SSIs.
Detailed Description
This randomized clinical trial will be investigating the use of preoperative chlorhexidine cloths, a chemical skin antiseptic agent effective on gram positive and gram negative bacteria, as an intervention to reduce the rate of surgical site infections (SSIs). The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths. The control group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care. The impact on women's health is significant, as a reduction in SSIs in this prevalent patient population can reduce the number of prolonged hospital stays, outpatient follow-ups for infection, hospital readmissions and health care costs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Chlorhexidine Cloth, Surgical Site Infection, Non-scheduled cesarean delivery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine Cloth
Arm Type
Experimental
Arm Description
The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths.
Arm Title
Standard Preoperative Care
Arm Type
No Intervention
Arm Description
The no intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care.
Intervention Type
Device
Intervention Name(s)
Chlorhexidine Cloth
Intervention Description
2% chlorhexidine gluconate cloth
Primary Outcome Measure Information:
Title
Rate of surgical site infection
Time Frame
Up to 6 weeks after cesarean delivery
Secondary Outcome Measure Information:
Title
Hospital length of stay
Time Frame
Up to 6 weeks after cesarean delivery
Title
Number of office visits
Time Frame
Up to 6 weeks after cesarean delivery
Title
Number of hospital readmissions for infection-related complications
Time Frame
Up to 6 weeks after cesarean delivery
Title
Rate of endometritis
Time Frame
Up to 6 weeks after cesarean delivery
Title
Rate of positive wound culture from wound
Time Frame
Up to 6 weeks after cesarean delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
undergoing non-scheduled cesarean delivery > 23 weeks gestation
Exclusion Criteria:
allergy to chlorhexidine, emergency cesarean delivery, evidence of infection at operative site
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Citations:
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28885421
Citation
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Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries
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