Evaluation of COVA™+ CARD in Adult Cardiac Surgery

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-28

Study Completion Date

2018-02-28

Brief Summary

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The aim of this observational study is to evaluate the safety of the guided healing and adhesion prevention membrane, COVA™+ CARD, in adult cardiac surgery. The causality of the collagen membrane according to the occurrence of peri and post-operative complications will be evaluated.

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Detailed Description

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Assessment of the safety of COVA™+ CARD, collagen membrane to prevent adhesion appearance, in cardiac surgery in adult patients:

* collection of post-operative complications, causality of the membrane
* collection of complications in the 3-month period after the surgery, causality of the membrane
* collection of peri-operative complications, causality of the membrane
* collection of complications, 3 months after the surgery
* assessment of the efficacy of COVA™+ CARD if re-operation
* assessment of the surgeon's satisfaction

Conditions

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Safety Tolerance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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cardiac surgery requiring a collagen membrane COVA™+

At the end of the cardiac surgery, the collagen membrane is implanted on the dissection area in order to prevent the formation of postoperative adhesions.

Intervention Type DEVICE