Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries
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|ClinicalTrials.gov Identifier: NCT04202471|
Recruitment Status : Withdrawn (COVID-19 pandemic)
First Posted : December 17, 2019
Last Update Posted : September 24, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|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|
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.
- Rate of surgical site infection [ Time Frame: Up to 6 weeks after cesarean delivery ]
- Hospital length of stay [ Time Frame: Up to 6 weeks after cesarean delivery ]
- Number of office visits [ Time Frame: Up to 6 weeks after cesarean delivery ]
- Number of hospital readmissions for infection-related complications [ Time Frame: Up to 6 weeks after cesarean delivery ]
- Rate of endometritis [ Time Frame: Up to 6 weeks after cesarean delivery ]
- Rate of positive wound culture from wound [ Time Frame: Up to 6 weeks after cesarean delivery ]
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
|United States, New York|
|North Shore University Hospital|
|Manhasset, New York, United States, 11030|