Antimicrobial Hernia Repair Device

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02730936

Enrollment

Registered

2016-04-07

Start date

2016-01-12

Completion date

2020-07-31

Last updated

2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernias, Ventral Hernias

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.

Interventions

DEVICEAntimicrobial Hernia Repair Device

hernia repair

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of patients that develop a surgical site infection	6 months	Surgical site infections (SSI) that will be included in this outcome measure are deep incisional, organ/space, and superficial incisional.

Secondary

Measure	Time frame	Description
Number of hernia recurrences	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	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026