Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT02129140
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.
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Notify Me18 year–80 year
All sexes
Observational
New York, 10029, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
observational group
Other names: Cook Biodesign hernia graft
Time frame: up to 2 years
Assessment of efficacy of the device and repair
Time frame: up to 2 years
Infections related to the surgical site or implantation of the device
Time frame: up to 2 years
Time frame: up to 2 years
Time frame: up to 2 years
Time frame: up to 2 years
Icahn School of Medicine at Mount Sinai
Other
Observational Study to Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign) for Midline Fascial Closure Reinforcement
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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