Evaluation of COVA™+ CARD in Adult Cardiac Surgery

Evaluation of the Tolerance and Efficacy of COVA™+ CARD in Adult Cardiac Surgery. A Prospective, Observational and Single Center Study.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03140098

Enrollment

Registered

2017-05-04

Start date

2017-02-28

Completion date

2018-02-28

Last updated

2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety, Tolerance

Keywords

Collagen membrane, Cardiac surgery, Postoperative complication

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

Interventions

DEVICEcardiac 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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026