search
Back to results

Antimicrobial Hernia Repair Device

Primary Purpose

Ventral Hernias, Incisional Hernias

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antimicrobial Hernia Repair Device
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernias

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field.

Exclusion Criteria:

  • Less than 21 years old
  • Unwilling or unable to sign and date the informed consent
  • Pregnant, breastfeeding, or planning to become pregnant prior to completing the study
  • Unable or unwilling to comply with follow-up schedule
  • Simultaneously participating in another investigational drug or device study.
  • Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Antimicrobial Hernia Repair Device

    Arm Description

    Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields.

    Outcomes

    Primary Outcome Measures

    Number of patients that develop a surgical site infection
    Surgical site infections (SSI) that will be included in this outcome measure are deep incisional, organ/space, and superficial incisional.

    Secondary Outcome Measures

    Number of hernia recurrences
    Hernia recurrences is the protrusion of abdominal tissue through a defect in the abdominal wall at the site of the hernia repaired during the index procedure.
    Frequency of procedural and post-operative adverse events
    The adverse events will be bowel erosion, bowl obstruction, delayed wound infection, fever, fistula formation, graft contraction, hernia recurrence, ileus, need for revision/resurgery, pain, premature degradation, wound dehiscence, and other wound complications.

    Full Information

    First Posted
    March 30, 2016
    Last Updated
    February 10, 2017
    Sponsor
    Cook Group Incorporated
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02730936
    Brief Title
    Antimicrobial Hernia Repair Device
    Official Title
    Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor decision to discontinue the study.
    Study Start Date
    January 12, 2016 (Anticipated)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cook Group Incorporated

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes

    5. Study Description

    Brief Summary
    This prospective early feasibility clinical study will collect information regarding the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated and contaminated (i.e., Class II and Class III) surgical fields.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventral Hernias, Incisional Hernias

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antimicrobial Hernia Repair Device
    Arm Type
    Experimental
    Arm Description
    Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields.
    Intervention Type
    Device
    Intervention Name(s)
    Antimicrobial Hernia Repair Device
    Intervention Description
    hernia repair
    Primary Outcome Measure Information:
    Title
    Number of patients that develop a surgical site infection
    Description
    Surgical site infections (SSI) that will be included in this outcome measure are deep incisional, organ/space, and superficial incisional.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Number of hernia recurrences
    Description
    Hernia recurrences is the protrusion of abdominal tissue through a defect in the abdominal wall at the site of the hernia repaired during the index procedure.
    Time Frame
    24 months
    Title
    Frequency of procedural and post-operative adverse events
    Description
    The adverse events will be bowel erosion, bowl obstruction, delayed wound infection, fever, fistula formation, graft contraction, hernia recurrence, ileus, need for revision/resurgery, pain, premature degradation, wound dehiscence, and other wound complications.
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient with ventral or incisional hernia that is to be surgically corrected in a Class II and Class III surgical field. Exclusion Criteria: Less than 21 years old Unwilling or unable to sign and date the informed consent Pregnant, breastfeeding, or planning to become pregnant prior to completing the study Unable or unwilling to comply with follow-up schedule Simultaneously participating in another investigational drug or device study. Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint.

    12. IPD Sharing Statement

    Learn more about this trial

    Antimicrobial Hernia Repair Device

    We'll reach out to this number within 24 hrs