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Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

This study is currently recruiting participants.
Verified May 2012 by Medline Industries
Sponsor:
Information provided by (Responsible Party):
Medline Industries
ClinicalTrials.gov Identifier:
NCT01364233
First received: May 27, 2011
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Medline Industries:

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


Estimated Enrollment: 10
Study Start Date: May 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MotifMesh Device: MotifMESH
Polytetrafluoroethylene (cPTFE) macroporous mesh
Device: MotifMESH
Surgical mesh

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364233

Contacts
Contact: Dumanian, MD 312-695-6086

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

No publications provided

Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT01364233     History of Changes
Other Study ID Numbers: PB-NU-2011-01
Study First Received: May 27, 2011
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013