Evaluation of COVA™+ CARD in Adult Cardiac Surgery

NCT03140098 | Withdrawn

• 1 other identifier: ETC 2017-002
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Safety; Tolerance

Keywords

Collagen membrane; Cardiac surgery; Postoperative complication

Outcome Measures

Primary Outcomes (1)

• Evaluation of the tolerance of COVA™+ CARD in cardiac surgery

  Recording of complications reported in the 3-month postoperative period and determination of the causality of the collagen membrane.

  3 months

Secondary Outcomes (1)

• Evaluation of the tolerance of COVA™+ CARD in cardiac surgery

  Hospitalization stay (up to 30 days)

Interventions

cardiac surgery requiring a collagen membrane COVA™+ DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will undergo a cardiac surgery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Biom'Up France SAS: lead

Related Links

• Potential interest of a new absorbable collagen membrane in the prevention of adhesions in paediatric cardiac surgery

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Madonna

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 4, 2017
• Study Start: February 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share