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Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04202471
Recruitment Status : Withdrawn (COVID-19 pandemic)
First Posted : December 17, 2019
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Moti Gulersen, Northwell Health

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.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Device: Chlorhexidine Cloth Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Preoperative Chlorhexidine Cloths to Reduce Surgical Site Infection in Non-Scheduled Cesarean Deliveries
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021


Arm Intervention/treatment
Experimental: Chlorhexidine Cloth
The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths.
Device: Chlorhexidine Cloth
2% chlorhexidine gluconate cloth

No Intervention: Standard Preoperative Care
The no intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care.



Primary Outcome Measures :
  1. Rate of surgical site infection [ Time Frame: Up to 6 weeks after cesarean delivery ]

Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Up to 6 weeks after cesarean delivery ]
  2. Number of office visits [ Time Frame: Up to 6 weeks after cesarean delivery ]
  3. Number of hospital readmissions for infection-related complications [ Time Frame: Up to 6 weeks after cesarean delivery ]
  4. Rate of endometritis [ Time Frame: Up to 6 weeks after cesarean delivery ]
  5. Rate of positive wound culture from wound [ Time Frame: Up to 6 weeks after cesarean delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT04202471


Locations
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United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Publications:

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Responsible Party: Moti Gulersen, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT04202471    
Other Study ID Numbers: 19-1040
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Moti Gulersen, Northwell Health:
Chlorhexidine Cloth
Surgical Site Infection
Non-scheduled cesarean delivery
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants