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

Ventral Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129140
• Other study ID #: GCO 14-0377
• Status: Completed
• Start date: April 2014
• Est. completion date: May 16, 2019

Study information

• Verified date: September 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 16, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Ventral Incisional Hernia

Intervention

Device:
• Hernia graft/mesh
observational group

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia Recurrence	Assessment of efficacy of the device and repair	up to 2 years
Secondary	Infections	Infections related to the surgical site or implantation of the device	up to 2 years
Secondary	Seromas		up to 2 years
Secondary	Rehospitalization		up to 2 years
Secondary	Re-operation		up to 2 years
Secondary	Mesh Removal		up to 2 years