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Bovine pericardium as prosthetic material in pediatric cardiac surgery - a Novel Tissue Engineered Material in India

Experience with a new Tissue Engineered Material in Paediatric Cardiac Surgery - TEM-CHD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/07/034695
Enrollment
50
Registered
2021-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: Q249- Congenital malformation of heart,unspecified

Interventions

None listed

Sponsors

Army Hospital Research and Referral
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients who will undergo cardiac surgery for congenital heart disease and in whom the Decellularized Bovine pericardium (Synkroscaff) membrane will be used.

Exclusion criteria

Exclusion criteria: 1.Patients in whom other prosthetic material will be used. 2.Patients who had cardiac interventions done pre operatively like attempted ASD, VSD device closures, balloon valvotomy procedures prior to surgery.

Design outcomes

Primary

MeasureTime frame
On echocardiography the following parameters will be evaluated for presence or absence of calcification, aneurysmal dilatation, leakages/tears, infective endocarditis, stenosis. (as per proforma) Timepoint: Outcome variables: The primary outcome variables will be noted on echocardiography. The incidence of calcification, aneurysmal dilatation around prosthesis, leakages/tears will be observed at regular intervals as follows In the immediate postoperative echocardiography At the time of discharge At 1 month post-operatively At 3 month post-operatively 6 month post-operatively And at 1 year post-operatively.

Secondary

MeasureTime frame
LeakageTimepoint: 1 year

Countries

India

Contacts

Public ContactNikhil Tiwari

Army Hospital Research and Referral

tiwari1972@gmail.com9579240272

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026