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This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).
cPTFEi s a mesh-like product designed to reduce associated post surgical complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MotifMesh | Other | Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MotifMESH | Device | Polytetrafluoroethylene (cPTFE) macroporous mesh |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Gregory A Dumanian, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Plastic Surgery | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MotifMesh | Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh MotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh MotifMESH: Surgical mesh |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MotifMesh | Participants received Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh | Hernia occurrence at one year after surgery | Posted | Number | participants | 1 year |
|
|
1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MotifMesh | Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh MotifMESH: Polytetrafluoroethylene (cPTFE) macroporous mesh MotifMESH: Surgical mesh |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Hematoma | Systematic Assessment | Small hematoma located in the lateral incision for performance of a components release, hematoma was drained and resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ed Drower | Medline Industries, Inc. | 847-643-3874 | edrower@medline.com |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
|
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