Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

Study Overview
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Brief Summary
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Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study. Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.

Official Title
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Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy

Conditions
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Surgical Wound Dehiscence, Wound Infection

Intervention / Treatment
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* Procedure: Negative pressure wound closure
* Procedure: Standard wound closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing Cesarean delivery. Patient at least 18 years of age. Weight greater than 199 pounds. Depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 4 centimeters. Exclusion Criteria: Weight less or equal to 199 pounds or less than 4 cm of subcutaneous tissue present. Inability to give proper informed consent. Inability to adhere to follow-up provisions of the study (return for 2 post-operative visits at 7-14 days post-op and between 4-6 weeks post-op). Patient less than 18 years of age.

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative pressure wound closure<br>Negative Pressure wound closure | Procedure: Negative pressure wound closure<br>* Applying negative pressure to primary wound closure<br>|
| Active Comparator: Standard wound closure<br>Standard Wound Closure | Procedure: Standard wound closure<br>* Standard wound closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Patients Experiencing a Wound Complication | Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma. | 6 Weeks post-partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Wound Dehiscence, Wound Infection, Obesity, Cesarean Delivery, Wound Closure, Negative Pressure wound closure