Clinical Trial Results:
Comparison of the efficacy of using a human acellular dermis (Epiflex®) against the surgical standard procedure for closing an open abdomen with respect to avoiding ventral hernia.
A monocenter, partly-blind, controlled, prospective and randomised phase-III clinical trial.
Summary
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EudraCT number |
2015-001309-14 |
Trial protocol |
DE |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Sep 2021
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First version publication date |
10 Sep 2021
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Other versions |
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Summary report(s) |
MINDED results statement_25Aug2021 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.