<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/NCT03293862</url>
  </required_header>
  <id_info>
    <org_study_id>2024878</org_study_id>
    <nct_id>NCT03293862</nct_id>
  </id_info>
  <brief_title>Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies</brief_title>
  <official_title>Prevention of Fascial Dehiscence With Prophylactic Onlay Mesh in Emergency Laparotomies: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Facial dehiscence elicit high morbidity and mortality. This complication may arise in more&#xD;
      than 8.5% of high-risk patients. Addressing risk factors and optimizing surgical technique&#xD;
      are guarded as mainstay measures for prevention, but their efficacy is questionable. The aim&#xD;
      of this study is to analyze the influence of using a polypropylene onlay prophylactic mesh on&#xD;
      the incidence of fascial dehiscence in emergency surgery and associated complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fascial dehiscence is associated with high morbidity and mortality rates. It occurs in more&#xD;
      than 8.5% of high-risk patients. Current preventive measures described are control of risk&#xD;
      factors and optimization of surgical technique. Despite that, the incidence of such&#xD;
      complication remained stable in the last decades, highlighting the low efficacy of such&#xD;
      measures. Polypropilene onlay mesh has been used to avoid incisional hernias in selected&#xD;
      elective patients, and could be useful in the prevention of fascial dehiscence. In emergency&#xD;
      situations, especially in contaminated and infected surgical procedures, safety and efficacy&#xD;
      of mesh is controversial. In this study the investigators aimed to evaluate the influence of&#xD;
      polypropilene prophylactic onlay mesh on the incidence of fascial dehiscence in high-risk&#xD;
      patients undergoing midline emergency laparotomy. As secondary outcome, the associated&#xD;
      morbidity, including surgical site occurence, will be analyzed. The study design will be a&#xD;
      randomized controlled trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Suture group and prophylactic mesh group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fascial dehiscence incidence</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical site occurence (SSO) incidence</measure>
    <time_frame>30 days or during hospital stay</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site occurrence requiring procedural intervention (SSOPI) incidence</measure>
    <time_frame>30 days or during hospital stay</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time (minutes),</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay (days)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit length of stay (days)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">145</enrollment>
  <condition>Surgical Wound Dehiscence</condition>
  <arm_group>
    <arm_group_label>Suture group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture only, without mesh, aiming a suture length to wound length ratio higher than four. Randomization occurs after fascial closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prophylactic mesh group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture aiming a suture length to wound length ratio higher than four AND further polypropilene onlay mesh. Randomization occurs after fascial closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>prophylactic polypropilene mesh</intervention_name>
    <description>Placement of onlay polypropilene prophylactic mesh after midline fascial closure.</description>
    <arm_group_label>Prophylactic mesh group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Midline Fascial Closure</intervention_name>
    <description>midline fascial closure using uninterrupted PDS 0 suture</description>
    <arm_group_label>Prophylactic mesh group</arm_group_label>
    <arm_group_label>Suture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>vacuum drainage system</intervention_name>
    <description>Placement of a subcutaneous vacuum drainage system</description>
    <arm_group_label>Prophylactic mesh group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Emergency laparotomy by midline incision&#xD;
&#xD;
          -  High risk for abdominal wound dehiscence: Risk index** ≥ 4,0 or ≥ 2,2 in combination&#xD;
             with at least one of the following: smoking, obesity, malnutrition or malignant&#xD;
             neoplasia.&#xD;
&#xD;
               -  Risk index is the sum of values associated with high-risk characteristics, based&#xD;
                  in the risk score for abdominal wall dehiscence published by van Ramshorst et.&#xD;
                  al. in World Journal of Surgery, 2010 (Rotterdam risk model):&#xD;
&#xD;
        Age category (in years)&#xD;
&#xD;
          -  40-49: 0.4&#xD;
&#xD;
          -  50-59: 0.9&#xD;
&#xD;
          -  60-69: 0.9&#xD;
&#xD;
          -  ≥70: 1.1&#xD;
&#xD;
        Male gender: 0.7&#xD;
&#xD;
        Chronic pulmonary disease: 0.7&#xD;
&#xD;
        Ascites: 1.5&#xD;
&#xD;
        Jaundice: 0.5&#xD;
&#xD;
        Anemia: 0.7&#xD;
&#xD;
        Emergency surgery: 0.6&#xD;
&#xD;
        Type of surgery:&#xD;
&#xD;
          -  Gallbladder/bile duct 0.7&#xD;
&#xD;
          -  Esophagus 1.5&#xD;
&#xD;
          -  Gastroduodenum 1.4&#xD;
&#xD;
          -  Small bowel 0.9&#xD;
&#xD;
          -  Large bowel 1.4&#xD;
&#xD;
          -  Vascular 1.3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-midline incisions or midline laparotomy measuring less than 1/4 the distance&#xD;
             between the xyphoid and the pubis, including laparoscopic surgery.&#xD;
&#xD;
          -  Diagnosis of incisional hernia or presence of previous mesh on site.&#xD;
&#xD;
          -  Midline laparotomy performed in less than 30 days.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe trauma with hemodynamic instability&#xD;
&#xD;
          -  Need for open abdomen or relaxing incisions&#xD;
&#xD;
          -  Need for re-laparotomy during the first 30 postoperative days, except cases in which&#xD;
             an abdominal wall dehiscence was diagnosed.&#xD;
&#xD;
          -  Death during the first 30 postoperative days, except cases in which an abdominal wall&#xD;
             dehiscence was diagnosed before the event.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>São</state>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Gomez Diaz CJ, Rebasa Cladera P, Navarro Soto S, Hidalgo Rosas JM, Luna Aufroy A, Montmany Vioque S, Corredera Cantarin C. [Validation of abdominal wound dehiscence's risk model]. Cir Esp. 2014 Feb;92(2):114-9. doi: 10.1016/j.ciresp.2012.12.008. Epub 2013 May 3. Spanish.</citation>
    <PMID>23648044</PMID>
  </reference>
  <results_reference>
    <citation>van Ramshorst GH, Nieuwenhuizen J, Hop WC, Arends P, Boom J, Jeekel J, Lange JF. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010 Jan;34(1):20-7. doi: 10.1007/s00268-009-0277-y.</citation>
    <PMID>19898894</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Edivaldo Massazo Utiyama</investigator_full_name>
    <investigator_title>MD, PhD, Full Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>laparotomy</keyword>
  <keyword>emergency surgery</keyword>
  <keyword>abdominal wound dehiscence</keyword>
  <keyword>prophylactic mesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Surgical Wound Dehiscence</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03293862
org study id: 2024878
nct id: NCT03293862
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Facial dehiscence elicit high morbidity and mortality. This complication may arise in more
      than 8.5% of high-risk patients. Addressing risk factors and optimizing surgical technique
      are guarded as mainstay measures for prevention, but their efficacy is questionable. The aim
      of this study is to analyze the influence of using a polypropylene onlay prophylactic mesh on
      the incidence of fascial dehiscence in emergency surgery and associated complications.
Fascial dehiscence is associated with high morbidity and mortality rates. It occurs in more
      than 8.5% of high-risk patients. Current preventive measures described are control of risk
      factors and optimization of surgical technique. Despite that, the incidence of such
      complication remained stable in the last decades, highlighting the low efficacy of such
      measures. Polypropilene onlay mesh has been used to avoid incisional hernias in selected
      elective patients, and could be useful in the prevention of fascial dehiscence. In emergency
      situations, especially in contaminated and infected surgical procedures, safety and efficacy
      of mesh is controversial. In this study the investigators aimed to evaluate the influence of
      polypropilene prophylactic onlay mesh on the incidence of fascial dehiscence in high-risk
      patients undergoing midline emergency laparotomy. As secondary outcome, the associated
      morbidity, including surgical site occurence, will be analyzed. The study design will be a
      randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Suture group and prophylactic mesh group
primary purpose: Prevention
masking: Single (Care Provider)
measure: Fascial dehiscence incidence
time frame: 30 days
measure: Surgical site occurence (SSO) incidence
time frame: 30 days or during hospital stay
measure: Surgical site occurrence requiring procedural intervention (SSOPI) incidence
time frame: 30 days or during hospital stay
measure: Operative time (minutes),
time frame: 30 days
measure: Hospital length of stay (days)
time frame: 30 days
measure: Intensive care unit length of stay (days)
time frame: 30 days
arm group label: Suture group
arm group type: Active Comparator
description: Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture only, without mesh, aiming a suture length to wound length ratio higher than four. Randomization occurs after fascial closure.
arm group label: Prophylactic mesh group
arm group type: Experimental
description: Patients randomized to this arm will undergo midline laparotomy closure using a PDS 0 continuous suture aiming a suture length to wound length ratio higher than four AND further polypropilene onlay mesh. Randomization occurs after fascial closure.
intervention type: Device
intervention name: prophylactic polypropilene mesh
description: Placement of onlay polypropilene prophylactic mesh after midline fascial closure.
arm group label: Prophylactic mesh group
intervention type: Procedure
intervention name: Midline Fascial Closure
description: midline fascial closure using uninterrupted PDS 0 suture
arm group label: Prophylactic mesh group
arm group label: Suture group
intervention type: Device
intervention name: vacuum drainage system
description: Placement of a subcutaneous vacuum drainage system
arm group label: Prophylactic mesh group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
citation: Gomez Diaz CJ, Rebasa Cladera P, Navarro Soto S, Hidalgo Rosas JM, Luna Aufroy A, Montmany Vioque S, Corredera Cantarin C. [Validation of abdominal wound dehiscence's risk model]. Cir Esp. 2014 Feb;92(2):114-9. doi: 10.1016/j.ciresp.2012.12.008. Epub 2013 May 3. Spanish.
PMID: 23648044
citation: van Ramshorst GH, Nieuwenhuizen J, Hop WC, Arends P, Boom J, Jeekel J, Lange JF. Abdominal wound dehiscence in adults: development and validation of a risk model. World J Surg. 2010 Jan;34(1):20-7. doi: 10.1007/s00268-009-0277-y.
PMID: 19898894
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Edivaldo Massazo Utiyama
investigator title: MD, PhD, Full Professor of Surgery
mesh term: Emergencies
mesh term: Surgical Wound Dehiscence
mesh term: Surgical Wound
sharing ipd: No