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Trial record 30 of 26588 for:    Anti-Infective Agents

Antimicrobial Hernia Repair Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02730936
Recruitment Status : Withdrawn (Sponsor decision to discontinue the study.)
First Posted : April 7, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

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.

Condition or disease Intervention/treatment Phase
Ventral Hernias Incisional Hernias Device: Antimicrobial Hernia Repair Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
Estimated Study Start Date : January 12, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Hernia

Arm Intervention/treatment
Experimental: Antimicrobial Hernia Repair Device
Antimicrobial hernia repair device for repair of ventral or incisional hernias in Class II and III surgical fields.
Device: Antimicrobial Hernia Repair Device
hernia repair




Primary Outcome Measures :
  1. Number of patients that develop a surgical site infection [ Time Frame: 6 months ]
    Surgical site infections (SSI) that will be included in this outcome measure are deep incisional, organ/space, and superficial incisional.


Secondary Outcome Measures :
  1. Number of hernia recurrences [ Time Frame: 24 months ]
    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.

  2. Frequency of procedural and post-operative adverse events [ Time Frame: 24 months ]
    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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT02730936     History of Changes
Other Study ID Numbers: 14-12
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Incisional Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Anti-Infective Agents
Anti-Bacterial Agents