<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/NCT04482140</url>
  </required_header>
  <id_info>
    <org_study_id>001GF</org_study_id>
    <nct_id>NCT04482140</nct_id>
  </id_info>
  <brief_title>Post Approval Study to Evaluate the Safety and Efficacy of Gentafoil Resorb</brief_title>
  <official_title>Post Approval Study to Evaluate the Safety and Efficacy of Gentafoil Resorb for the Prevention of Tissue Adhesions.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advanced Medical Solutions Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Advanced Medical Solutions Ltd.</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>
      Single arm study to evaluate the safety and efficacy of Genta-Foil resorb® for the prevention&#xD;
      of tissue adhesions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 2022</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Restoration of hand mobility</measure>
    <time_frame>Up to 30 days post-surgery</time_frame>
    <description>Restoration of hand mobility will be assessed using Tendon Total Active Motion (TAM). Restriction of TAM post-surgery is indicative of tissue adhesions, therefore this measure (when compared with the unaffected contralateral finger(s)) will demonstrate presence / absence of of tissue adhesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of device related adverse events</measure>
    <time_frame>Up to 30 days post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to resumption of normal daily activities</measure>
    <time_frame>Up to 30 days post-surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound closure without complications (number of patients without complications)</measure>
    <time_frame>Up to 30 days post-surgery</time_frame>
    <description>Surgical wound will be assessed by the investigator for dehiscence. Wound dehiscence will be classified as any separation of the apposed edges of the surgical wound (epidermis, dermis or subcutaneous layers).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient pain scores from baseline to end of follow-up</measure>
    <time_frame>Up to 30 days post-surgery</time_frame>
    <description>Assessed using VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician satisfaction with the Genta-Foil device</measure>
    <time_frame>Immediately post-surgery</time_frame>
    <description>Assessment of satisfaction with device conformability and ease of use. Assessed using a Likert-type scale.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Tissue Adhesions, Surgery-Induced</condition>
  <arm_group>
    <arm_group_label>Genta-Foil resorb</arm_group_label>
    <description>Genta-Foil resorb® is a transparent collagen foil that forms a temporary barrier between the functional structures during the critical phase of wound healing. As a result, the ability of the tissue layers to slide against each other is retained. The absorbability of equine collagen means the foil can be left in place and does not require removal. The addition of the antibiotic Gentamicin is for self-protection since collagen implants are prone to bacterial contamination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Genta-Foil resorb</intervention_name>
    <description>Use of Genta-Foil resorb to prevent adhesions in patients undergoing hand surgery</description>
    <arm_group_label>Genta-Foil resorb</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are undergoing hand surgery with the Genta-Foil resorb device.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is male or female, ≥18 years of age;&#xD;
&#xD;
          2. Subject is willing and able to give written informed consent;&#xD;
&#xD;
          3. Subject is willing and able to comply with the protocol assessments at time of surgery&#xD;
             and during the post-surgical follow up period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who decline the invitation to take part.&#xD;
&#xD;
          2. Subjects who are known to be non-compliant with medical treatment,&#xD;
&#xD;
          3. Subjects who are known to be sensitive to any of the device components eg Gentamicin.&#xD;
&#xD;
          4. Subjects with impaired renal function/autoimmune diseases/neuromuscular disease such&#xD;
             as Parkinsons or Myasthenia Gravis&#xD;
&#xD;
          5. Subjects taking Aminoglycoside antibiotics&#xD;
&#xD;
          6. Subject is pregnant or actively breastfeeding;&#xD;
&#xD;
          7. Subject has active or potential infection&#xD;
&#xD;
          8. Subject has any significant or unstable medical or psychiatric condition that, in the&#xD;
             opinion of the Investigator, would interfere with his/her ability to participate in&#xD;
             the study;&#xD;
&#xD;
          9. Subject is currently enrolled in another clinical study.&#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>Stephen Lipscombe</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Helens and Knowsley Teaching Hospitals NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Susan Clark</last_name>
    <phone>01606863500</phone>
    <email>susan.clark@admedsol.com</email>
  </overall_contact>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 14, 2022</last_update_submitted>
  <last_update_submitted_qc>February 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hand Mobility, Wound Healing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Adhesions</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/NCT04482140
org study id: 001GF
nct id: NCT04482140
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Single arm study to evaluate the safety and efficacy of Genta-Foil resorb® for the prevention
      of tissue adhesions
observational model: Cohort
time perspective: Prospective
measure: Restoration of hand mobility
time frame: Up to 30 days post-surgery
description: Restoration of hand mobility will be assessed using Tendon Total Active Motion (TAM). Restriction of TAM post-surgery is indicative of tissue adhesions, therefore this measure (when compared with the unaffected contralateral finger(s)) will demonstrate presence / absence of of tissue adhesions.
measure: Incidence of device related adverse events
time frame: Up to 30 days post-surgery
measure: Time to resumption of normal daily activities
time frame: Up to 30 days post-surgery
measure: Wound closure without complications (number of patients without complications)
time frame: Up to 30 days post-surgery
description: Surgical wound will be assessed by the investigator for dehiscence. Wound dehiscence will be classified as any separation of the apposed edges of the surgical wound (epidermis, dermis or subcutaneous layers).
measure: Change in patient pain scores from baseline to end of follow-up
time frame: Up to 30 days post-surgery
description: Assessed using VAS
measure: Clinician satisfaction with the Genta-Foil device
time frame: Immediately post-surgery
description: Assessment of satisfaction with device conformability and ease of use. Assessed using a Likert-type scale.
arm group label: Genta-Foil resorb
description: Genta-Foil resorb® is a transparent collagen foil that forms a temporary barrier between the functional structures during the critical phase of wound healing. As a result, the ability of the tissue layers to slide against each other is retained. The absorbability of equine collagen means the foil can be left in place and does not require removal. The addition of the antibiotic Gentamicin is for self-protection since collagen implants are prone to bacterial contamination.
intervention type: Device
intervention name: Genta-Foil resorb
description: Use of Genta-Foil resorb to prevent adhesions in patients undergoing hand surgery
arm group label: Genta-Foil resorb
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen Lipscombe
role: Principal Investigator
affiliation: St Helens and Knowsley Teaching Hospitals NHS Trust
last name: Susan Clark
phone: 01606863500
email: susan.clark@admedsol.com
responsible party type: Sponsor
mesh term: Tissue Adhesions
sharing ipd: No