PROphylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
Condition: Wound Complication
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This study will assess whether a negative pressure wound vacuum therapy (NPWT) on closed
      incisions decreases the risk of wound complications among obese patients after cesarean
      section

      All patients having a cesarean section in labor or presenting to the triage unit and
      requiring a cesarean section will be eligible

      Main study intervention: this involves the use of a negative pressure wound vacuum therapy on
      a closed incision.
    

Detailed description: 
      Objectives To evaluate whether there is a decrease in wound complications among obese
      patients who are treated with closed incision NPWT versus standard post cesarean section
      wound care protocol.

      Primary outcome variable(s) The primary outcome variable is wound complications defined as
      any readmission for a wound issue within four weeks of discharge, infection, or wound
      breakdown.

      Secondary outcome will look at patient quality of life among those with NPWT versus usual
      care arm.

      A survey addressing pain, breast feeding questions and ability to perform activity of daily
      living will be administered during the inpatient stay and at the postpartum visit.

      Background Obesity, defined as a body mass index (BMI) 30kg/m2, continues to be a growing
      epidemic in the United States. According to National Center for Health Statistics Data1,
      almost one third of adults and 17% of youth were obese in 2009-2010. Furthermore,
      non-Hispanic Blacks have the age-adjusted rates of obesity (49.5%). In a study by Chu et al
      analyzing data from 26 states in the Pregnancy Risk Assessment Monitoring System (PRAMS)
      database, 20% of women who delivered were obese and in certain ethnic and insurance
      subgroups, the rates were as high as 33%. In 2008, according to reports by the Pennsylvania
      State statistics, the rates of obesity in the city of Philadelphia were as high as 64%.
      Multiple studies have demonstrated the increased risks for diabetes, hypertension and adverse
      pregnancy outcomes (APO) during pregnancy in the obese population. In addition, obesity is a
      well established independent risk factor for the development of a wound complication or
      infection after a cesarean delivery, with rates ranging from 10-15% . Certain measures such
      as antibiotic prophylaxis and closure of the subcutaneous space are techniques that have
      demonstrated a decreased incidence of wound disruption. Currently no randomized controlled
      trials have looked at the effects of surgical approach or choice of abdominal incision in the
      obese or extremely obese woman undergoing cesarean delivery. However, the few retrospective
      studies that have addressed this issue have demonstrated mixed results. Given the paucity of
      randomized controlled trials evaluating the prevention of wound complications in obese women
      undergoing cesarean delivery, a recent review by Tipton emphasized the necessity for such
      trials to evaluate methods with which to improve postoperative wound care and healing in this
      high risk cohort. In the past decade, negative pressure wound therapy (NPWT) has become
      accepted in the treatment of expediting healing of open wounds 15-18. NPWT is a method in
      which a vacuum device is placed on the wound in order to remove excess interstitial fluid,
      increase tissue vascularity, decrease bacterial colonization, and place mechanical stress on
      adjacent wound edges which aids in wound contractility and closure. Therefore, the positive
      effects of NPWT on open wounds have been well studied and established. Recent studies have
      been performed to assess a potential effect of NPWT on closed incisions non-obstetric fields.
      A recent study by Grauhan et al compared the effects of NPWT over closed sternotomy incisions
      in obese patients compared to conventional sterile wound dressing and noted a significant
      reduction in the rates of wound infection in those treated with NPWT.

      Another study by Vargo assessed the effects of NPWT on closed incisions in patients
      undergoing abdominal therapy compared to a historical control also noted a decreased wound
      infection rate and no evidence of skin necrosis. In contrast, a recent study by Masden et al.
      looked at rates of infection and dehiscence in patients with multiple comorbidities status
      post predominantly lower extremity wounds and did not appreciate a difference between the
      NPWT group and dry dressing group24. Therefore, the need for further studies assessing the
      benefits of NPWT on various anatomical sites has been clearly established.
    

Intervention name(s): Closed incision wound vacuum (Prevena)
Intervention type(s): Device
Intervention description(s): wound vacuum to be placed on a closed incision
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity, cesarean section, wound complication