A Post Market Study on the Use of Cormatrix® Cangaroo ECM® (Extracellular Matrix) Envelope (SECURE)
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|ClinicalTrials.gov Identifier: NCT02530970|
Recruitment Status : Completed
First Posted : August 21, 2015
Results First Posted : March 11, 2020
Last Update Posted : March 24, 2020
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1025 participants|
|Official Title:||A Post Market Observational Study to Obtain Additional Information on the Use of Cormatrix® Cangaroo ECM® Envelope|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||April 2018|
- Proportion of Subjects With ECM Related Adverse Events [ Time Frame: Participants were followed for an average of 235.0 days. ]ECM related adverse events were collected at all study visits.
- Number of Participants With Major Pocket Infections [ Time Frame: Participants were followed for an average of 235.0 days. ]Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530970
|Study Director:||Andrew Green||CorMatrix Cardiovascular, Inc.|