Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)
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|ClinicalTrials.gov Identifier: NCT02129140|
Recruitment Status : Active, not recruiting
First Posted : May 2, 2014
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment|
|Ventral Incisional Hernia||Device: Hernia graft/mesh|
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|
|Estimated Enrollment :||30 participants|
|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|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Hernia repair patients implanted with biologic hernia graft during surgery
Device: Hernia graft/mesh
Other Name: Cook Biodesign hernia graft
- Hernia Recurrence [ Time Frame: up to 2 years ]Assessment of efficacy of the device and repair
- Infections [ Time Frame: up to 2 years ]Infections related to the surgical site or implantation of the device
- Seromas [ Time Frame: up to 2 years ]
- Rehospitalization [ Time Frame: up to 2 years ]
- Re-operation [ Time Frame: up to 2 years ]
- Mesh Removal [ Time Frame: up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129140
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Joel J Bauer, MD||Icahn School of Medicine at Mount Sinai|