Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preoperative Chlorhexidine Cloths to Reduce Surgical Site Infection in Non-Scheduled Cesarean Deliveries

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Device: Chlorhexidine Cloth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing non-scheduled cesarean delivery > 23 weeks gestation Exclusion Criteria: allergy to chlorhexidine, emergency cesarean delivery, evidence of infection at operative site

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine Cloth<br>The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths. | Device: Chlorhexidine Cloth<br>* 2% chlorhexidine gluconate cloth<br>|
| No Intervention: Standard Preoperative Care<br>The no intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of surgical site infection |  | Up to 6 weeks after cesarean delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay |  | Up to 6 weeks after cesarean delivery | 
| Number of office visits |  | Up to 6 weeks after cesarean delivery | 
| Number of hospital readmissions for infection-related complications |  | Up to 6 weeks after cesarean delivery | 
| Rate of endometritis |  | Up to 6 weeks after cesarean delivery | 
| Rate of positive wound culture from wound |  | Up to 6 weeks after cesarean delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine Cloth, Surgical Site Infection, Non-scheduled cesarean delivery