Evaluation of COVA™+ CARD in Adult Cardiac Surgery

Withdrawn

• Conditions: Safety; Tolerance

• Registration Number: NCT03140098
• Lead Sponsor: Biom'Up France SAS

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2017-02
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 18 years of age or older
• Cardiac surgery using COVA™+ CARD

Exclusion Criteria

• In accordance with the instruction for use (IFU) of the medical device.
• Refusal of participation to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the tolerance of COVA™+ CARD in cardiac surgery	3 months	Recording of complications reported in the 3-month postoperative period and determination of the causality of the collagen membrane.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the tolerance of COVA™+ CARD in cardiac surgery	Hospitalization stay (up to 30 days)	Recording of the immediate postoperative complications and determination of the causality of the collagen membrane.