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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
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment
Ventral Incisional Hernia 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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




Primary Outcome Measures :
  1. Hernia Recurrence [ Time Frame: up to 2 years ]
    Assessment of efficacy of the device and repair


Secondary Outcome Measures :
  1. Infections [ Time Frame: up to 2 years ]
    Infections related to the surgical site or implantation of the device

  2. Seromas [ Time Frame: up to 2 years ]
  3. Rehospitalization [ Time Frame: up to 2 years ]
  4. Re-operation [ Time Frame: up to 2 years ]
  5. Mesh Removal [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Joel J Bauer, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02129140     History of Changes
Other Study ID Numbers: GCO 14-0377
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Keywords provided by Icahn School of Medicine at Mount Sinai:
hernia repair
ventral incisional hernia
biologic mesh
hernia graft

Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes