xml: <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/NCT05966961</url>
    </required_header>
    <id_info>
      <org_study_id>AAG-G-H-2201</org_study_id>
      <nct_id>NCT05966961</nct_id>
    </id_info>
    <brief_title>Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery</brief_title>
    <acronym>POLYNOVO-CHD</acronym>
    <official_title>'All Comer'/'Real-world' Registry-based Randomized, Prospective, Multicenter Clinical Trial to Evaluate the Incidence of Complications Using Novosyn® CHD Suture Versus Polyglactin 910 Suture to Close the Wound After Emergency or Elective Laparotomy or Laparoscopic Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aesculap AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>B.Braun Surgical SA</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Aesculap AG</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to elucidate, if the colonization of bacteria is lower on the&#xD;
        Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by&#xD;
        the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will&#xD;
        generate further clinical evidence for the use and the benefit of a Chlorhexidine coated&#xD;
        suture used to close the wound after an emergency or elective laparoscopic or laparotomy&#xD;
        surgery. The benefit for individual patients lies in the early diagnosis of complications and&#xD;
        in the optimized postoperative controls of a clinical study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2028</completion_date>
    <primary_completion_date type="Anticipated">June 2028</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>30 Days</target_duration>
    <primary_outcome>
      <measure>Frequency of surgical site infection (superficial (A1) and deep (A2)</measure>
      <time_frame>until 30 days + 5 days after surgery.</time_frame>
      <description>The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Handling of the suture material</measure>
      <time_frame>intraoperatively</time_frame>
      <description>Assessment of the handling of the suture material intraoperatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>until discharge (approximately 10 days after surgery)</time_frame>
      <description>Number of days the patient has to stay in hospital after emergency or elective laparotomy or laparoscopic surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to return to work</measure>
      <time_frame>until 30 days + 5 days after surgery.</time_frame>
      <description>Number of days the patient needed to return to work after emergency or elective laparotomy or laparoscopic surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Surgical Site Infection (SSI)</measure>
      <time_frame>at discharge (approximately 10 days after surgery)</time_frame>
      <description>Incidence of Surgical Site Infection (SSI) (superficial (A1), deep (A2) and organ space (A3)) at the time of discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class</measure>
      <time_frame>until 30 days + 5 days after surgery</time_frame>
      <description>Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class (Class I clean, Class II clean/contaminated, Class III contaminated, Class IV dirty/infected)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative Rate of postoperative complications</measure>
      <time_frame>discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.</time_frame>
      <description>Number of postoperative complications of any kind for descriptive analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative Rate of reoperation</measure>
      <time_frame>at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.</time_frame>
      <description>Number of reoperation of any kind for descriptive analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative Rate of suture removal due to wound problems</measure>
      <time_frame>at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.</time_frame>
      <description>Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) for descriptive analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative Rate of Re-suturing</measure>
      <time_frame>at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.</time_frame>
      <description>Rate of Re-suturing of any kind for descriptive analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hernia rate</measure>
      <time_frame>30 days + 5 days postoperatively</time_frame>
      <description>Number of Wound Hernia including umbilical hernia verified by ultra-sound examination</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">2998</enrollment>
    <condition>Surgical Site Infection</condition>
    <arm_group>
      <arm_group_label>Novosyn®</arm_group_label>
      <description>Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Polyglactin 910</arm_group_label>
      <description>Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Novosyn® in emergency or elective laparotomy or laparoscopic surgery</intervention_name>
      <description>Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.</description>
      <arm_group_label>Novosyn®</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery</intervention_name>
      <description>Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.</description>
      <arm_group_label>Polyglactin 910</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients undergoing wound closure after emergency or elective laparoscopic or laparotomy&#xD;
          surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  Age≥ 18 years&#xD;
  &#xD;
            -  Not incapacitated patient&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  No exclusion criteria except patients with allergy or hypersensitivity to&#xD;
               chlorhexidine&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Antonio José Torres Garcia, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital San Carlos, Madrid</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Oriol Estallo Sanz</last_name>
      <phone>+34935866200</phone>
      <email>info@bbraun.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ricard Rosique</last_name>
      <email>info@bbraun.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chlorhexidine coated suture</keyword>
    <keyword>emergency laparoscopic surgery</keyword>
    <keyword>emergency laparotomy surgery</keyword>
    <keyword>elective laparoscopic surgery</keyword>
    <keyword>elective laparotomy surgery</keyword>
    <keyword>Novosyn®</keyword>
    <keyword>Polyglactin 910</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Surgical Wound Infection</mesh_term>
      <mesh_term>Emergencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966961
  org study id: AAG-G-H-2201
  nct id: NCT05966961
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to elucidate, if the colonization of bacteria is lower on the
        Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by
        the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will
        generate further clinical evidence for the use and the benefit of a Chlorhexidine coated
        suture used to close the wound after an emergency or elective laparoscopic or laparotomy
        surgery. The benefit for individual patients lies in the early diagnosis of complications and
        in the optimized postoperative controls of a clinical study.
  observational model: Case-Control
  time perspective: Prospective
  measure: Frequency of surgical site infection (superficial (A1) and deep (A2)
  time frame: until 30 days + 5 days after surgery.
  description: The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2).
  measure: Handling of the suture material
  time frame: intraoperatively
  description: Assessment of the handling of the suture material intraoperatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor).
  measure: Length of hospital stay
  time frame: until discharge (approximately 10 days after surgery)
  description: Number of days the patient has to stay in hospital after emergency or elective laparotomy or laparoscopic surgery
  measure: Time to return to work
  time frame: until 30 days + 5 days after surgery.
  description: Number of days the patient needed to return to work after emergency or elective laparotomy or laparoscopic surgery
  measure: Incidence of Surgical Site Infection (SSI)
  time frame: at discharge (approximately 10 days after surgery)
  description: Incidence of Surgical Site Infection (SSI) (superficial (A1), deep (A2) and organ space (A3)) at the time of discharge
  measure: Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class
  time frame: until 30 days + 5 days after surgery
  description: Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class (Class I clean, Class II clean/contaminated, Class III contaminated, Class IV dirty/infected)
  measure: Cumulative Rate of postoperative complications
  time frame: discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.
  description: Number of postoperative complications of any kind for descriptive analysis
  measure: Cumulative Rate of reoperation
  time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
  description: Number of reoperation of any kind for descriptive analysis
  measure: Cumulative Rate of suture removal due to wound problems
  time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
  description: Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) for descriptive analysis
  measure: Cumulative Rate of Re-suturing
  time frame: at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.
  description: Rate of Re-suturing of any kind for descriptive analysis
  measure: Hernia rate
  time frame: 30 days + 5 days postoperatively
  description: Number of Wound Hernia including umbilical hernia verified by ultra-sound examination
  arm group label: Novosyn®
  description: Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine
  arm group label: Polyglactin 910
  description: Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine
  intervention type: Device
  intervention name: Novosyn® in emergency or elective laparotomy or laparoscopic surgery
  description: Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
  arm group label: Novosyn®
  intervention type: Device
  intervention name: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery
  description: Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.
  arm group label: Polyglactin 910
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Antonio José Torres Garcia, Prof. Dr.
  role: Principal Investigator
  affiliation: Hospital San Carlos, Madrid
  last name: Oriol Estallo Sanz
  phone: +34935866200
  email: info@bbraun.com
  last name: Ricard Rosique
  email: info@bbraun.com
  responsible party type: Sponsor
  mesh term: Surgical Wound Infection
  mesh term: Emergencies
  sharing ipd: No