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PROphylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population (PROVAC)

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ClinicalTrials.gov Identifier: NCT02128997
Recruitment Status : Completed
First Posted : May 1, 2014
Results First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
Kinetic Concepts, Inc.
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.


Condition or disease Intervention/treatment Phase
Wound Complication Device: Closed incision wound vacuum (Prevena) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Wound VACuum Therapy to Decrease Rates of Cesarean Section in the Obese Population
Actual Study Start Date : May 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Closed Incision Wound vacuum (Prevena)
Closed incision wound vacuum (Prevena)
Device: Closed incision wound vacuum (Prevena)
wound vacuum to be placed on a closed incision

No Intervention: Routine Wound Care
This arm includes patients having a cesarean section with routine wound care



Primary Outcome Measures :
  1. Number of Participants With Wound Complications [ Time Frame: Four weeks after cesarean section ]
    The primary outcome variable was a composite of wound morbidity at 4 weeks postpartum including SSI and/or wound opening


Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: Postpartum day 2 ]
    On postoperative day 2, all patients were administered a pain scale: Rank sharp pain (0-10), 10 being worst possible sharp pain.

  2. Tingling Pain Scores [ Time Frame: Postpartum day 2 ]
    On postoperative day 2, all patients were administered a pain scale: Rank tingling pain (0-10), 10 being worst possible tingling pain

  3. Postpartum Length of Stay [ Time Frame: Until hospital discharge and then for 4 weeks follow up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Key inclusion criteria BMI greater than or equal to 30 kg/m2 at less than or equal to 22 weeks of gestation Subject is laboring Subject is having an unplanned cesarean section Subject will have Pfannenstiel Skin Incision Subject has the ability to take a picture and email it to a secure account Subject receives prenatal care in the University of Pennsylvania health system and plans to follow up postpartum in the system Subject is greater than or equal to 18 years of age

Key exclusion criteria Subject cannot read or speak English Subject is not 18 years of age Subject does not have ability to send a picture by email Subject has preexisting diabetes mellitus (Type 1 or Type 2) , is using chronic steroids or immune-suppressants, OR being actively treated for a malignancy Subject is undergoing a scheduled cesarean section Subject is allergic to silver


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128997


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Kinetic Concepts, Inc.
Investigators
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Principal Investigator: Celeste Durnwald, MD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02128997     History of Changes
Other Study ID Numbers: 819579
First Posted: May 1, 2014    Key Record Dates
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017
Last Verified: September 2017

Keywords provided by University of Pennsylvania:
obesity, cesarean section, wound complication

Additional relevant MeSH terms:
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Wounds and Injuries