Hernia of Abdominal Wall Clinical Trial
Official title:
Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE Cohort)
Incisional hernia is the most frequently seen long term complication in surgery causing much
morbidity and even mortality in patients. Despite studies on the optimal closing technique
for laparotomies, the risk for incisional hernia after midline incision remains about 5-20%.
It has been established that implementing a mesh reduces recurrence of the incisional hernia
but still the results of repair are often disappointing. Incisional hernias can become
increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy,
fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair
the incisional hernia by means of a synthetic mesh and other augmentation tools need to be
implemented.
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.
n/a
Status | Clinical Trial | Phase | |
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Active, not recruiting |
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Multi-Center Study To Examine The Use Of Flex HD® And Strattice In The Repair Of Large Abdominal Wall Hernias
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Phase 4 | |
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N/A |