Safety Study of MotifMESH (cPTFE) in Abdominal Surgery

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

Completed

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Key information

Conditions

Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Plastic Surgery

Chicago, Illinois, 60611, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MotifMESH

Device

Polytetrafluoroethylene (cPTFE) macroporous mesh

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Official study title

A Prospective Outcome Study of Condensed Fenestrated PTFE Mesh (MotifMESH) in Non-sterile Abdominal Wall Defects

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jun 2, 2011
Registry last updated: Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed