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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.
 
ClinicalTrials.gov Identifier: NCT01364233
Recruitment Status : Completed
First Posted : June 2, 2011
Results First Posted : December 4, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Medline Industries

Study Description
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Brief Summary:
This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).

Condition or disease Intervention/treatment Phase
Hernia Device: MotifMESH Not Applicable

Detailed Description:
cPTFEi s a mesh-like product designed to reduce associated post surgical complications.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arms and Interventions
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Arm Intervention/treatment
MotifMesh
Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh
 Device: MotifMESH
Polytetrafluoroethylene (cPTFE) macroporous mesh


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh [ Time Frame: 1 year ]
    Hernia occurrence at one year after surgery


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Illinois
Division of Plastic Surgery
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Medline Industries
Investigators
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Principal Investigator: Gregory A Dumanian, MD Northwestern University
More Information
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Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT01364233    
Other Study ID Numbers: PB-NU-2011-01
First Posted: June 2, 2011    Key Record Dates
Results First Posted: December 4, 2018
Last Update Posted: February 26, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical