Health Condition 1: null- Surgery
Conditions
Interventions
None listed
Sponsors
Medanta The Medicity
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients undergoing cardiovascular and thoracic surgery who require use of Coseal as a treatment strategy. 2.Patient undergoing open, Video Assisted surgery and robotic surgery to be included and analysed as subgroups 3.Written informed consent obtained from the patient or legal representative for data collection post surgery in patients who had Coseal used intraoperatively (data privacy laws).
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to components of the investigational product 2.Known Immune system disorders, immunodeficiency 3.Concomitant use of any other anti-adhesion product 4.Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days 5.Unplanned re-operation in case of use for anti-adhesion 6.Contraindications for use of Coseal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Cardio vascular sealing Efficacy of Coseal in prevention or reduction of adhesion in re-do surgeries for patients with staged operations for congenital cardiac malformation re-operated on during the follow-up period of the registry Air leak: incidence of immediate (at the time of closure) and prolonged post-operative air leak, Use in redo surgery for air leak.Timepoint: 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Cardiovascular (sealing and adhesion prevention) 2.Thoracic and Lung a. Sealing the suture/ staple line on table Use of buttressing b. Total operative time c. Drain output d. Drain duration e.Length of hospital stay 3.In all cases, a.intra and post-operative blood loss b.FFP, Transfusion 4.Others a.Surgeons satisfaction (VAS + Simple questionnaire Efficacy/Ease of use/Safety/Confidence of surgeon) Timepoint: 18 months | — |
Countries
India
Contacts
Public ContactDr Ali Zamir Khan
Medanta, The Medicity
Outcome results
None listed