Phase
Condition
N/ATreatment
Phasix™ Mesh
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must be ≥ 18 years of age
Elective, open midline laparotomy ≥ 5 cm
Willing and able to provide written informed consent
Hernia risk equal to moderate or greater
Exclusion
Exclusion Criteria:
Previous hernia repair
Emergent surgery
Creation of skin flaps is preplanned
Preplanned 2nd surgery
Active skin pathology
Life expectancy less than 24 months
Pregnant or planning to become pregnant
Receiving a medication/medical condition that may adversely affect wound healing
ASA Class > IV
Enrolled in another clinical trial
Site personnel directly involved with this trial
Any condition that would preclude the use of the device or the subject formcompleting the follow-up requirements
Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
Two separate incisions are created
Prior onlay mesh
Surgeon is unable to fully close the fascia
The surgery requires more than a single piece of mesh
Contraindication to placement of mesh
CDC Class IV/Active Infection
Breastfeeding
Study Design
Study Description
Connect with a study center
Krankenhaus der Barmherzigen Brüder Graz
Graz, 08020
AustriaSite Not Available
Krankenhaus der Barmherzigen Brüder Graz
Graz 2778067, 08020
AustriaActive - Recruiting
Universitair Ziekenhuis Gent
Gent, 09000
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Ghent 2797656, 09000
BelgiumActive - Recruiting
CHU de Dijon Bourgogne
Dijon, 21079
FranceSite Not Available
CHU de Dijon Bourgogne
Dijon 3021372, 21079
FranceActive - Recruiting
Centre Hospitalier Universitaire de Lille
Lille, 59000
FranceSite Not Available
Centre Hospitalier Universitaire de Lille
Lille 2998324, 59000
FranceActive - Recruiting
Hôpital Paris St Joseph
Paris, 75014
FranceSite Not Available
Hôpital Paris St Joseph
Paris 2988507, 75014
FranceActive - Recruiting
Hôpital Lyon Sud
Pierre-Benite, 69495
FranceSite Not Available
Hôpital Lyon Sud
Pierre-Bénite 2987314, 69495
FranceActive - Recruiting
CHU Reims
Reims, 51092
FranceSite Not Available
CHU Reims
Reims 2984114, 51092
FranceActive - Recruiting
Hopitaux Universitaires de Strasbourg
Strasbourg, 67000
FranceSite Not Available
Hopitaux Universitaires de Strasbourg
Strasbourg 2973783, 67000
FranceActive - Recruiting
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
Berlin, 13353
GermanySite Not Available
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery
Berlin, 13353
GermanySite Not Available
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
Berlin 2950159, 13353
GermanySite Not Available
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery
Berlin 2950159, 13353
GermanySite Not Available
Asklepios Klinik Barmbek
Hamburg, 22307
GermanySite Not Available
Asklepios Klinik Barmbek
Hamburg 2911298, 22307
GermanyActive - Recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
GermanySite Not Available
Universitätsklinikum Heidelberg
Heidelberg 2907911, 69120
GermanyActive - Recruiting
Bundeswehrzentralkrankenhaus Koblenz
Koblenz, 56072
GermanySite Not Available
Bundeswehrzentralkrankenhaus Koblenz
Koblenz 2886946, 56072
GermanyActive - Recruiting
Dignity Health
Phoenix, Arizona 85013
United StatesSite Not Available
Dignity Health
Phoenix 5308655, Arizona 5551752 85013
United StatesActive - Recruiting
Keck Medical Center of USC
Los Angeles, California 90033
United StatesSite Not Available
University of California San Francisco
San Francisco, California 94143
United StatesSite Not Available
Keck Medical Center of USC
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
University of California San Francisco
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Hartford Hospital
Hartford, Connecticut 06102
United StatesSite Not Available
St. Francis Hospital and Medical Center
Hartford, Connecticut 06105
United StatesSite Not Available
Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102
United StatesSite Not Available
St. Francis Hospital and Medical Center
Hartford 4835797, Connecticut 4831725 06105
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Emory University
Atlanta 4180439, Georgia 4197000 30322
United StatesTerminated
OSF Saint Francis Medical Center
Peoria, Illinois 61637
United StatesSite Not Available
OSF Saint Francis Medical Center
Peoria 4905687, Illinois 4896861 61637
United StatesSite Not Available
Indiana University
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
University of Kentucky Research Foundation
Lexington, Kentucky 40508
United StatesSite Not Available
University of Kentucky Research Foundation
Lexington 4297983, Kentucky 6254925 40508
United StatesActive - Recruiting
Tulane University School of Medicine
New Orleans, Louisiana 70112
United StatesSite Not Available
Tulane University School of Medicine
New Orleans 4335045, Louisiana 4331987 70112
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Minneapolis VA Health Care System
Minneapolis, Minnesota 55417
United StatesSite Not Available
Minneapolis VA Health Care System
Minneapolis 5037649, Minnesota 5037779 55417
United StatesSite Not Available
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
United StatesActive - Recruiting
St. Luke's Hospital
Kansas City, Missouri 64111
United StatesSite Not Available
Cox Health
Springfield, Missouri 65807
United StatesSite Not Available
St. Luke's Hospital
Kansas City 4393217, Missouri 4398678 64111
United StatesSite Not Available
Cox Health
Springfield 4409896, Missouri 4398678 65807
United StatesSite Not Available
Washington University
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Nebraska Medical Center
Omaha, Nebraska 68106
United StatesSite Not Available
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United StatesSite Not Available
Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68106
United StatesSite Not Available
Nebraska Methodist Hospital
Omaha 5074472, Nebraska 5073708 68114
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
New York Presbyterian Hospital-Columbia University Medical Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
United StatesSite Not Available
Atrium Health
Charlotte, North Carolina 28203
United StatesSite Not Available
Duke University
Durham, North Carolina 27708
United StatesSite Not Available
New Hanover Regional Medical Center
Wilmington, North Carolina 28401
United StatesSite Not Available
Atrium Health
Charlotte 4460243, North Carolina 4482348 28203
United StatesSite Not Available
Duke University
Durham 4464368, North Carolina 4482348 27708
United StatesSite Not Available
New Hanover Regional Medical Center
Wilmington 4499379, North Carolina 4482348 28401
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
The Ohio State University
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Baptist Clinical Research Institute
Memphis, Tennessee 38163
United StatesSite Not Available
Vanderbilt University
Nashville, Tennessee 37232
United StatesSite Not Available
Baptist Clinical Research Institute
Memphis 4641239, Tennessee 4662168 38163
United StatesSite Not Available
Vanderbilt University
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia 25304
United StatesSite Not Available
CAMC Health Education and Research Institute, Inc.
Charleston 4801859, West Virginia 4826850 25304
United StatesSite Not Available

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