Negative Pressure Wound Therapy After Cesarean Delivery

Study Overview
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Brief Summary
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This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. The study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. The investigators will then compare the rates of wound infection and wound complications between these two groups. It is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.

Detailed Description
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Infectious complications have been found to be five times higher in women undergoing a cesarean delivery compared to a vaginal delivery. Known risk factors for wound complications are obesity, premature rupture of membranes, diabetes mellitus, hypertensive disorders, emergency cesarean delivery, twin delivery, chorioamnionitis, increased surgical blood loss and preeclampsia. This study is aimed at determining whether or not the use of a suction device placed on the wound instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The investigators will compare the results from the participants of this study to an existing data set of historical controls who underwent cesarean delivery. The study involves placing a single use, portable negative wound pressure system kept in place while in the hospital after surgery (on average 48-72 hours) in women who meet criteria for increased risk of wound complications. The investigators will then compare the rates of wound infection and wound complications between these two groups.

Official Title
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Negative Pressure Wound Therapy to Prevent Post Operative Wound Complications Following Cesarean Delivery in Women at High Risk for Wound Complications

Conditions
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Major Puerperal Infection, Postpartum, Wound Complications, Wound Seroma, Caesarean Section Wound Separation, Wound Infection

Intervention / Treatment
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* Device: Prevena negative pressure wound system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Having a cesarean delivery Has one or more of the following conditions: BMI > 30 Anemia Preeclampsia (sever or mild) Hemolysis, elevated liver enzymes and low platelets (HELLP) Urgent procedure Rupture of membranes prior to surgery for > 4 hours Chorioamnionitis Hypertension Diabetes (Gestational or pre-gestational) Dense adhesive disease Exclusion Criteria: Age < 18 years old Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative pressure pump<br>Will have the Prevena negative pressure wound system placed at the time of surgery. | Device: Prevena negative pressure wound system<br>* Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Complication Rate | Wound infection, separation or deep infection | Up to 6 weeks from time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean delivery, Postpartum infection, Wound complications, Wound seroma, Wound separation, Wound infection, Negative pressure