An Open Label,Observational, Real Time Data Capturing of Usage & Outcome of Coseal
Recruitment status was: Not yet recruiting
This study is Open- Label, Observational, Prospective, Real-time data capturing of Usage, Outcome & Physician satisfaction of Coseal in Cardio- Vascular-Thoracic Operative and Re- Operative procedures.
Objective of this study is to assess current practice pattern and best practice sharing of usage of Coseal by collecting data on (1) Sealing suture lines along arterial and venous reconstruction(2) Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extent of post surgical adhesion enforcement of suture lines in lung resection procedures (3) From this data to document and generate a real life experience on the use of Coseal in cardio vascular and thoracic surgery.
Number of expected patient enrollment is 750 from 20 participating sites.
|Study Design:||Time Perspective: Prospective|
|Official Title:||An Open- Label,Multicentre, Observational, Prospective, Real-time Data Capturing of Usage, Outcome & Physician Satisfaction of Coseal in Cardio- Vascular- Thoracic Operative and Re- Operative Procedures|
- Cardio Vascular Outcome [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]To report the effectiveness and safety of COSEAL in the control of anastomotic suture line and needle hole suture bleeding during vascular reconstruction by checking the incidence of immediate anastomotic sealing and the presence of persistent intra-operative and postoperative bleeding
- Cardiovascular (sealing and adhesion prevention): [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]To Capture total operative time,nature and duration of first operation,nature and duration of redo operation, and time for dissection from sternotomy to end of dissection for prevention of adhesions )
- Thoracic and Lung (Sealing and Adhesion prevention) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706640
|Medanta, The Medicity|
|Gurgaon, Haryana, India, 122 001|
|Principal Investigator:||Dr. Ali Z Khan, MS,FRCS,FRCS||Medanta, The Medicity|