Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-03-31

Brief Summary

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This study will monitor surgically repaired large abdominal hernias requiring condensed fenestrated polytetrafluoroethylene mesh (cPTFE).

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Detailed Description

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cPTFEi s a mesh-like product designed to reduce associated post surgical complications.

Conditions

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Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MotifMesh

Condensed polytetrafluoroethylene (cPTFE, MotifMESH) mesh

Group Type OTHER

MotifMESH

Intervention Type DEVICE

Polytetrafluoroethylene (cPTFE) macroporous mesh

Interventions

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MotifMESH

Polytetrafluoroethylene (cPTFE) macroporous mesh

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No