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

NCT02129140 | Completed

• 1 other identifier: GCO 14-0377
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Incisional Hernia

Keywords

hernia repair; ventral incisional hernia; biologic mesh; hernia graft

Outcome Measures

Primary Outcomes (1)

• Hernia Recurrence

  Assessment of efficacy of the device and repair

  up to 2 years

Secondary Outcomes (5)

• Infections

  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

Study Arms (1)

Hernia graft/mesh

Hernia repair patients implanted with biologic hernia graft during surgery

Device: Hernia graft/mesh

Interventions

Hernia graft/mesh DEVICE

observational group

Also known as: Cook Biodesign hernia graft

Hernia graft/mesh

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Joel J Bauer, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: April 1, 2014
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

US (1)