Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01364233
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
Medline Industries

Brief Summary:
Surgically repair of large abdominal hernias requires prosthetic materials such as mesh-like products. A relatively new synthetic product cPTFE is designed as a cost effective alternative to reduce associated post surgical complications. The study will monitor patients over a one year period.

Condition or disease Intervention/treatment Phase
Hernia Device: MotifMESH Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Outcome Study of Condensed Fenestrated PTFE Mesh (MotifMESH) in Non-sterile Abdominal Wall Defects
Study Start Date : May 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
MotifMesh Device: MotifMESH
Polytetrafluoroethylene (cPTFE) macroporous mesh
Device: MotifMESH
Surgical mesh

Primary Outcome Measures :
  1. Diminished Incisional hernia recurrence [ Time Frame: One year follow up. ]
    Determine the rate of potential surgical repairs.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired

Exclusion Criteria:

Non-pregnant, breast feeding or plans to become pregnant during the study; Using adequate birth control methods and agrees to continue using those methods for the duration of the study

Confirmation of incisional hernia or fascial defect by CT scan within 6 months Incisional hernia or facial defect has no necrotic tissue. Such as fascial dehiscence, evisceration, small or large bowel repair, stoma manipulation, small chronic abdominal skin wounds, bowel obstruction

Acceptable state of health and nutrition with pre-albumin levels of ≥ 15 mg/dL (0.15 g/L), serum albumin ≥ 2.0 g/dL (20 g/L). No abnormal pre-surgery laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study.

For subjects with Diabetes Mellitus, HbA1C <12%

BMI ≤ 40 kg/m²

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 identifier (NCT number): NCT01364233

United States, Illinois
Division of Plastic Surgery
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Medline Industries
Principal Investigator: Gregory A Dumanian, MD Northwestern University

Responsible Party: Medline Industries Identifier: NCT01364233     History of Changes
Other Study ID Numbers: PB-NU-2011-01
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014