Clinical trial NCT04202471: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgical Site Infection
Keywords: Chlorhexidine Cloth
Surgical Site Infection
Non-scheduled cesarean delivery
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of surgical site infection
timeFrame: Up to 6 weeks after cesarean delivery
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Up to 6 weeks after cesarean delivery
measure: Number of office visits
timeFrame: Up to 6 weeks after cesarean delivery
measure: Number of hospital readmissions for infection-related complications
timeFrame: Up to 6 weeks after cesarean delivery
measure: Rate of endometritis
timeFrame: Up to 6 weeks after cesarean delivery
measure: Rate of positive wound culture from wound
timeFrame: Up to 6 weeks after cesarean delivery
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
References:
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