Antimicrobial Hernia Repair Device

Ventral Hernias Clinical Trial

Official title:

Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02730936
• Other study ID #: 14-12
• Status: Withdrawn
• Phase: N/A
• First received: March 30, 2016
• Last updated: February 10, 2017
• Start date: January 12, 2016
• Est. completion date: July 2020

Study information

• Verified date: February 2017
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2020
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Incisional Hernias
• Ventral Hernias

Intervention

Device:
• Antimicrobial Hernia Repair Device
hernia repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	24 months
Secondary	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.	24 months