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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

Tracking Information
First Submitted Date  ICMJE May 27, 2011
First Posted Date  ICMJE June 2, 2011
Results First Submitted Date  ICMJE August 29, 2017
Results First Posted Date  ICMJE December 4, 2018
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE May 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)		 Incisional hernia recurrence [ Time Frame: One year follow up. ]
Determine the rate of potential surgical repairs.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of MotifMESH (cPTFE) in Abdominal Surgery
Official Title  ICMJE A Prospective Outcome Study of Condensed Fenestrated PTFE Mesh (MotifMESH) in Non-sterile Abdominal Wall Defects
Brief Summary This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).
Detailed Description cPTFEi s a mesh-like product designed to reduce associated post surgical complications.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hernia
Intervention  ICMJE Device: MotifMESH
Polytetrafluoroethylene (cPTFE) macroporous mesh
Study Arms  ICMJE MotifMesh
Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh
Intervention: Device: MotifMESH
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2011)		 10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01364233
Other Study ID Numbers  ICMJE PB-NU-2011-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Medline Industries
Original Responsible Party Dumanian/ Principal Investigator, Northwestern University
Current Study Sponsor  ICMJE Medline Industries
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory A Dumanian, MD Northwestern University
PRS Account Medline Industries
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP