Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)

Observational Study to Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign) for Midline Fascial Closure Reinforcement

The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently FDA-approved for implantation to reinforce soft tissues where weakness exists, but the investigators would like to collect additional follow-up information to continue to assess the durability of the repair after placement of the hernia mesh. This follow-up would include the collection of information about complications such as infections and seromas (collections of fluid around the surgery site), as well as hernia recurrence and quality of life questionnaires. Patients who qualify to take part in this study have been diagnosed with a ventral incisional hernia and will have been scheduled for a surgical hernia repair. This surgery will be an "open" surgical procedure and reinforcing your tissue with material is indicated for this type of hernia repair.

Study Overview

• Status: Completed
• Conditions: Ventral Incisional Hernia
• Intervention / Treatment: Device: Hernia graft/mesh

Detailed Description

Prior to their scheduled surgery, the patient will be consented and will complete a brief quality of life survey. They will also be asked some questions about their medical history that pertain to the study, such as current/ past abdominal infections and surgeries, history of the hernia, comorbidities, etc.

During the surgery, some key data points will be recorded by the research coordinator, such as time of surgery, type of case, size of mesh used, size of the hernia defect, technique used, type of sutures used, etc. The mesh will be placed either retrorectus or intraperitoneally, after the component separation is complete. The mesh will not be used as a "bridge," and the fascial layers will be closed completely.

The research staff may photograph the repair of an enrolled patient's hernia during their treatment and will supply a copy of the photograph to Cook Medical, Inc. if the sponsor's review is requested. Any photograph taken for research purposes will be kept in a password-protected, encrypted database separate from any patient identifying information.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study team will screen the office schedules of the investigators for patients presenting for open bowel resection at the Mount Sinai Medical Center. Patients who meet the eligibility criteria will be asked if they are interested in volunteering to participate in the study.

Description

Inclusion Criteria:

• Patients undergoing a ventral incisional hernia repair with mesh
• Age range between 18 and 80 years old

Exclusion Criteria:

• Patients currently enrolled in a clinical trial.
• Patients with a BMI over 40
• Patients in whom the fascial layers cannot be closed or in whom "bridging" would be used
• Patients with a current abdominal abscess or infection
• Patients with healing disorders
• Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hernia graft/mesh; Hernia repair patients implanted with biologic hernia graft during surgery	Device: Hernia graft/mesh; observational group; Other Names: Cook Biodesign hernia graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia Recurrence	Assessment of efficacy of the device and repair	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infections	Infections related to the surgical site or implantation of the device	up to 2 years
Seromas		up to 2 years
Rehospitalization		up to 2 years
Re-operation		up to 2 years
Mesh Removal		up to 2 years

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Joel J Bauer, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): May 16, 2019
• Study Completion (Actual): May 16, 2019

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimate): May 2, 2014

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: hernia repair; biologic mesh; ventral incisional hernia; hernia graft
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: GCO 14-0377