Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medline Industries
ClinicalTrials.gov Identifier:
NCT01364233
First received: May 27, 2011
Last updated: March 24, 2014
Last verified: March 2014
  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:


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.


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

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
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 ClinicalTrials.gov identifier: 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

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: March 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014