<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01661348</url>
  </required_header>
  <id_info>
    <org_study_id>Prevena-Smith</org_study_id>
    <nct_id>NCT01661348</nct_id>
  </id_info>
  <brief_title>The Use of the Prevena Incision Management System to Reduce Post-operative Cesarean Delivery Wound Complications</brief_title>
  <official_title>Reduction of Post Operative Wound Complications in Patients Undergoing Cesarean Delivery With the Use of the Prevena Incision Management System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim 1: Assess the effectiveness of the Prevena Incision Management System in decreasing&#xD;
      postoperative surgical site infections in the obese parturient undergoing non-emergent&#xD;
      cesarean delivery.&#xD;
&#xD;
      Aim 2: Assess patient satisfaction after using the Prevena Incision Management System&#xD;
      following a non-emergent cesarean delivery.&#xD;
&#xD;
      Our overall long term goal is to reduce morbidity and incidence of surgical site infection&#xD;
      (SSI) in obese parturient who undergo non-emergent cesarean delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the United States, the cesarean delivery rate continues to rise. In 2007, approximately&#xD;
      32% of all births occurred by Cesarean delivery, translating to 1.4 million women who&#xD;
      underwent this operative procedure. Oklahoma is on par with the national average, with 33.6 %&#xD;
      of births occuring by Cesarean delivery (1). Although in 2006 Cesarean delivery was the most&#xD;
      commonly performed surgical procedure in the United States, it remains vulnerable to common,&#xD;
      as well as rare, complications. Despite continued advances in surgical and aseptic technique,&#xD;
      surgical site infections (SSI) continue to be an area of concern for patients, physicians,&#xD;
      hospitals, and insurers.&#xD;
&#xD;
      In addition to their negative impact on patient quality of life, surgical site infections&#xD;
      (SSI) have been estimated to require an additional three thousand dollars per infection in&#xD;
      healthcare expenditure (2). In the surgical patient, it has been estimated that SSI account&#xD;
      for 25 to 38% of hospital acquired infections (3-4) and 2-5% of patients undergoing surgery&#xD;
      of any type will develop a SSI (5). In cesarean delivery in particular, rates of SSI are&#xD;
      between 3 to 15%, depending on the population, definition of SSI, and modifiable risk factors&#xD;
      (6). In particular, one factor shown to increase risk of SSI in multiple studies is obesity&#xD;
      with odds ratios 1.1-4.79 depending on degree of BMI stratification (6-8). Given its&#xD;
      prevalence and cost, SSI represents a postoperative complication with far reaching&#xD;
      consequences and making it an area of increasing focus for research.&#xD;
&#xD;
      Recently, negative pressure wound therapy has come to the forefront in demonstrating improved&#xD;
      healing and reduced complications in open and closed surgical wounds of various types. A&#xD;
      review of the literature illustrates that prophylactic negative pressure wound therapy device&#xD;
      effectiveness in reducing SSI has not been widely evaluated in cesarean deliveries. The goal&#xD;
      of this study is to evaluate wound infection rates with the use of the Prevena Incision&#xD;
      Management System in obese patients undergoing non-emergent cesarean delivery at a tertiary&#xD;
      care center. We propose to initiate a randomized clinical trial of the Prevena Incision&#xD;
      Management System in a novel population of patients at high risk of surgical site infection.&#xD;
      Given the possibility of unexpected challenges, we propose to begin this project with a pilot&#xD;
      study in order to help elucidate factors that may need to be including in a larger study in&#xD;
      the future. Also, we anticipate that the pilot study will give us a better insight into the&#xD;
      rates of wound complications and potential difference between groups in order to better power&#xD;
      a larger study.&#xD;
&#xD;
      Rationale for study: Obese patients undergoing Cesarean deliveries have frequent SSIs&#xD;
      secondary to modifiable and non-modifiable risk factors. A randomized controlled trial of&#xD;
      Prevena Incision Management System, a single use negative pressure therapy unit designed for&#xD;
      placement over clean closed surgical incisions, will help reduce rates of surgical site&#xD;
      infections and increase the overall quality of life of our patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Did not receive funding.&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">July 2014</completion_date>
  <primary_completion_date type="Anticipated">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Wound Infections</measure>
    <time_frame>The percent of patients with wound infections will be summarized at the 5-7 day post-operative assessment, the 14-21 day post-operative assessment, and the 6-week follow-up visit. The rate of wound infections will be evaluated at each time point.</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Prevena System placement</arm_group_label>
    <description>Subjects randomized to this group will receive standard skin preparation and closure followed by application of Prevena Incision Management System (Kinetic Concepts, Inc; San Antonio, TX) negative pressure wound therapy unit (experimental group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care postoperative care</arm_group_label>
    <description>Subjects randomized to this group will receive a standard surgical skin preparation, closure, and dressing (control group).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All eligible patients will be approached for consent to participate in the study prior to&#xD;
        surgical procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women greater than or equal to 18-years-of-age having a non-emergent Cesarean&#xD;
             delivery, primary or repeat procedure, without evidence of active infection at the&#xD;
             time of the procedure&#xD;
&#xD;
               -  Patient with BMI ≥ 30 kg/m2 at the time of hospital admission&#xD;
&#xD;
               -  Patient able to provide informed consent for study&#xD;
&#xD;
               -  Patient able to complete follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
               -  Females under the age of 18&#xD;
&#xD;
               -  Known sensitivity to silver due to the presence of silver in the skin interface&#xD;
                  layer of the Prevena&#xD;
&#xD;
               -  Patients unable to consent&#xD;
&#xD;
               -  Patients in active labor&#xD;
&#xD;
               -  Patients with a diagnosis of preterm premature rupture of membranes&#xD;
&#xD;
               -  Patients with known or suspected infection at the time of Cesarean delivery&#xD;
&#xD;
               -  Patients with a contraindication to use of the Prevena Incision Management System&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine M Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elise Eckhardt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>July 26, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>October 15, 2013</last_update_submitted>
  <last_update_submitted_qc>October 15, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cesarian section</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Incision management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01661348
org study id: Prevena-Smith
nct id: NCT01661348
lead sponsor: 
has dmc: No
Aim 1: Assess the effectiveness of the Prevena Incision Management System in decreasing
      postoperative surgical site infections in the obese parturient undergoing non-emergent
      cesarean delivery.

      Aim 2: Assess patient satisfaction after using the Prevena Incision Management System
      following a non-emergent cesarean delivery.

      Our overall long term goal is to reduce morbidity and incidence of surgical site infection
      (SSI) in obese parturient who undergo non-emergent cesarean delivery.
In the United States, the cesarean delivery rate continues to rise. In 2007, approximately
      32% of all births occurred by Cesarean delivery, translating to 1.4 million women who
      underwent this operative procedure. Oklahoma is on par with the national average, with 33.6 %
      of births occuring by Cesarean delivery (1). Although in 2006 Cesarean delivery was the most
      commonly performed surgical procedure in the United States, it remains vulnerable to common,
      as well as rare, complications. Despite continued advances in surgical and aseptic technique,
      surgical site infections (SSI) continue to be an area of concern for patients, physicians,
      hospitals, and insurers.

      In addition to their negative impact on patient quality of life, surgical site infections
      (SSI) have been estimated to require an additional three thousand dollars per infection in
      healthcare expenditure (2). In the surgical patient, it has been estimated that SSI account
      for 25 to 38% of hospital acquired infections (3-4) and 2-5% of patients undergoing surgery
      of any type will develop a SSI (5). In cesarean delivery in particular, rates of SSI are
      between 3 to 15%, depending on the population, definition of SSI, and modifiable risk factors
      (6). In particular, one factor shown to increase risk of SSI in multiple studies is obesity
      with odds ratios 1.1-4.79 depending on degree of BMI stratification (6-8). Given its
      prevalence and cost, SSI represents a postoperative complication with far reaching
      consequences and making it an area of increasing focus for research.

      Recently, negative pressure wound therapy has come to the forefront in demonstrating improved
      healing and reduced complications in open and closed surgical wounds of various types. A
      review of the literature illustrates that prophylactic negative pressure wound therapy device
      effectiveness in reducing SSI has not been widely evaluated in cesarean deliveries. The goal
      of this study is to evaluate wound infection rates with the use of the Prevena Incision
      Management System in obese patients undergoing non-emergent cesarean delivery at a tertiary
      care center. We propose to initiate a randomized clinical trial of the Prevena Incision
      Management System in a novel population of patients at high risk of surgical site infection.
      Given the possibility of unexpected challenges, we propose to begin this project with a pilot
      study in order to help elucidate factors that may need to be including in a larger study in
      the future. Also, we anticipate that the pilot study will give us a better insight into the
      rates of wound complications and potential difference between groups in order to better power
      a larger study.

      Rationale for study: Obese patients undergoing Cesarean deliveries have frequent SSIs
      secondary to modifiable and non-modifiable risk factors. A randomized controlled trial of
      Prevena Incision Management System, a single use negative pressure therapy unit designed for
      placement over clean closed surgical incisions, will help reduce rates of surgical site
      infections and increase the overall quality of life of our patients.
observational model: Case-Control
time perspective: Prospective
measure: Rate of Wound Infections
time frame: The percent of patients with wound infections will be summarized at the 5-7 day post-operative assessment, the 14-21 day post-operative assessment, and the 6-week follow-up visit. The rate of wound infections will be evaluated at each time point.
arm group label: Prevena System placement
description: Subjects randomized to this group will receive standard skin preparation and closure followed by application of Prevena Incision Management System (Kinetic Concepts, Inc; San Antonio, TX) negative pressure wound therapy unit (experimental group).
arm group label: Standard of care postoperative care
description: Subjects randomized to this group will receive a standard surgical skin preparation, closure, and dressing (control group).
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Katherine M Smith, MD
role: Principal Investigator
affiliation: University of Oklahoma
last name: Elise Eckhardt, MD
role: Principal Investigator
affiliation: University of Oklahoma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Surgical Wound