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Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364233
First Posted: June 2, 2011
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Medline Industries
  Purpose
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

  Eligibility

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
Criteria

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
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): NCT01364233


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

Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT01364233     History of Changes
Other Study ID Numbers: PB-NU-2011-01
First Submitted: May 27, 2011
First Posted: June 2, 2011
Last Update Posted: October 12, 2017
Last Verified: March 2014