Antimicrobial Hernia Repair Device
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|ClinicalTrials.gov Identifier: NCT02730936|
Recruitment Status : Withdrawn (Sponsor decision to discontinue the study.)
First Posted : April 7, 2016
Last Update Posted : February 13, 2017
Cook Group Incorporated
Information provided by (Responsible Party):
Cook Group Incorporated
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Primary Outcome Measures :
- 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 :
- 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.
- 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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