Abdominal Wall Repair With Strattice in Germany: a Cohort Study
NCT ID: NCT02168231
Last Updated: 2018-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2017-02-01
2018-12-31
Brief Summary
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In the recent years the use of biological meshes has been gaining popularity. Recent reports of the use of collagen-based prosthesis have suggested that they support new vessel growth, do not excite a significant foreign body reaction, form fewer adhesions, are well incorporated into host tissues with minimal wound contraction, and can be used in grossly contaminated wounds with fewer infective complications. Biologic meshes are harvested from a source tissue and processed for medical use but they vary widely in their processing methods. They include tissues of human or animal origins, both chemically cross-linked and non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current studies investigating the effectiveness of these meshes are small and have short periods of follow-up. These shortcomings can be explained to high cost of the meshes and unclear indication when to use a biological mesh.
The aim of this study is to investigate the short and long term effects of the Strattice biological mesh. The investigators will also inquire why a biologic mesh was used and what the direct and indirect costs were.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Complex abdominal wall repair Strattice
Complex abdominal wall repair Strattice
Complex abdominal wall repair Strattice
Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice)
Interventions
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Complex abdominal wall repair Strattice
Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* Abdominal wall repair
* Strattice mesh implantation prior to inclusion in BASE cohort
Exclusion Criteria
* No signed informed consent
* Other operation than abdominal wall repair
* Other mesh than Strattice mesh
18 Years
ALL
No
Sponsors
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Unfallkrankenhaus Berlin
OTHER
Johann Wolfgang Goethe University Hospital
OTHER
Diakoniekrankenhaus Friederikenstift
OTHER
Krankenhaus Agatharied Hausham
UNKNOWN
Technical University of Munich
OTHER
St. Josefs-Hospital Wiesbaden GmbH
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Ruth Kaufmann, MD
PhD fellow
Principal Investigators
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Ruth Kaufmann, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Trauma Hospital Berlin
Berlin, , Germany
Johann Wolfgang Goethe-University
Frankfurt am Main, , Germany
Diakoniekrankenhaus Friederikenstiftung
Hanover, , Germany
Agatharied Hospital
Hausham, , Germany
Klinikum rechts der Isar, Technical University of Munich
München, , Germany
St. Josefs-Hospital Wiesbaden
Wiesbaden, , Germany
Countries
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References
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Kaufmann R, Isemer FE, Strey CW, Jeekel J, Lange JF, Woeste G. Non-cross-linked biological mesh in complex abdominal wall hernia: a cohort study. Langenbecks Arch Surg. 2020 May;405(3):345-352. doi: 10.1007/s00423-020-01881-4. Epub 2020 Apr 22.
Other Identifiers
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BASE cohort study
Identifier Type: -
Identifier Source: org_study_id
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