This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

This study has been completed.
Information provided by (Responsible Party):
Medline Industries Identifier:
First received: May 27, 2011
Last updated: March 24, 2014
Last verified: March 2014
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 Intervention Phase
Hernia Device: MotifMESH Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Medline Industries:

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

Enrollment: 10
Study Start Date: May 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MotifMesh Device: MotifMESH
Polytetrafluoroethylene (cPTFE) macroporous mesh
Device: MotifMESH
Surgical mesh


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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Medline Industries Identifier: NCT01364233     History of Changes
Other Study ID Numbers: PB-NU-2011-01
Study First Received: May 27, 2011
Last Updated: March 24, 2014 processed this record on September 19, 2017