Vacuum Assisted Closure for Cesarean Section

Study Overview
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Brief Summary
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To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.

Detailed Description
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The prevalence of obesity (defined as body mass index (BMI, kg/m2) ≥ 30) has significantly increased, affecting approximately 35% of adult females in the United States, according to CDC 2009-2010 statistics. Obesity has a significant impact on pregnancy, including increased need for cesarean section and post-operative wound complications. Infection rates have been reported to be between 10 and 30%. The advent in 1997 of negative pressure therapy (NPT), also known as vacuum assisted closure (VAC), has vastly changed wound care management. Briefly, VAC has been traditionally applied to a chronic wound to create negative or sub-atmospheric pressure, thus promoting wound healing by decreasing edema and increasing blood flow and formation of granulation tissue. Use of this therapy at the time of primary closure of a surgical incision (first trialed in 2006 and termed Incisional VAC) has provided a promising approach to reducing post-operative wound infection. Incisional VAC has been explored primarily in the orthopedic and cardiothoracic fields, but very few studies have examined the use on abdominal incisions, and only one to date on cesarean section incisions.

Official Title
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Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Device: Vacuum-assisted closure
* Device: Standard sterile dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that have undergone cesarean section for delivery; have a BMI greater or equal to 35. All cases of cesarean section including primary and repeat, scheduled and urgent. Exclusion Criteria: Patients who deliver vaginally; age less than 18 years old; silver allergy; non-English speaking

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vacuum-assisted closure (VAC)<br>Prevena (VAC) device | Device: Vacuum-assisted closure<br>* Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.<br>* Other names: Incisional VAC;|
| Active Comparator: Standard sterile dressing<br>Standard sterile dressing | Device: Standard sterile dressing<br>* Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative wound infection | Determine number of post-operative wound infections | 6 weeks post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of seroma | Calculate incidence of seroma | 6 weeks post-operative | 
| Rate of hematoma | Calculate incidence of hematoma | 6 weeks post-operative | 
| Deep and superficial infection | Calculate incidence of deep and superficial infection | 6 weeks post-operative | 
| Readmission for infection | Calculate incidence of readmission to hospital for infection due to cesarean incision | 6 weeks post-operative | 
| Re-operation | Calculate incidence of re-operation to patients enrolled in study | 6 weeks post-operative | 
| Antibiotic treatment | Calculate incidence of need for antibiotic treatment for enrolled patients | 6 weeks post-operative |