Safety Study of MotifMESH (cPTFE) in Abdominal Surgery
A Prospective Outcome Study of Condensed Fenestrated PTFE Mesh (MotifMESH) in Non-sterile Abdominal Wall Defects
1 other identifier
interventional
10
1 country
1
Brief Summary
This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
December 4, 2018
CompletedFebruary 26, 2019
February 1, 2019
2.8 years
May 27, 2011
August 29, 2017
February 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh
Hernia occurrence at one year after surgery
1 year
Study Arms (1)
MotifMesh
OTHERCondensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh
Interventions
Eligibility Criteria
You may qualify if:
- Has a non-sterile abdominal wall defect (incisional hernia or fascial defect) and needs to be repaired
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Plastic Surgery
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ed Drower
- Organization
- Medline Industries, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory A Dumanian, MD
Northwestern University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2011
First Posted
June 2, 2011
Study Start
May 1, 2011
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
February 26, 2019
Results First Posted
December 4, 2018
Record last verified: 2019-02