In patients undergoing cardiac surgery the saphenous leg vein is used to replace veins used in coronary artery bypass grafts (CABG) surgery. MedDRA version: 7.1 Level: LLT Classification code 10006894
Conditions
Interventions
Product Name: LibersealTM
Product Code: FS014
Pharmaceutical Form: Powder and solvent for sealant
INN or Proposed INN: Fibrinogen
Current Sponsor code: Fibrinogen Component
Concentration unit: mg mi
Sponsors
Committee of Management, Common Services Agency T/A Scottish National Blood Transfusion Service
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing elective coronary artery bypass graft surgery (CABG) or CABG plus any other procedure which uses the saphenous vein in the leg as a donor site. Patients over 16 year of age. Patients who have given written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Female patients of a child bearing age who are pregnant or not taking adequate contraception. Patients witha known history of adverse reactions to plasma products. Patients under 16 years of age. Patients enrolled on another clinical study in the last 6 months involving study medication with the potential to interact with Fibrin Sealant. Patients requiring emergency cardiac surgery. Patients taking Warfarin or any other anti-coagulants a day before surgery (although current hospital policy is to stop anti-coagulant therapy seven days before elective cardiac surgery). This will be checked by performing an INR test within 24 hours before surgery. Any patient with INR>1.5 will not be randomised into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether Fibrin Sealant would have a beneficial effect in the reducing the rate of leg wound complications including infection in patients undergoing cardiac surgery. ;Secondary Objective: To examine the clinical, social, psychological and financial aspects of the treatment. To compare the use of SNBTS Fibrin Sealant in the prevention of wound problems with conventional treatment for closure of the wound. ;Primary end point(s): To demonstrate improvements in wound healing with significant reduction in wound complications. Wound complication defined as - broken down / or discharging wound with or without positive microbiological culture or an intact wound with clear signs of inflammation in the surroounding area (heat, redness, tenderness etc). The patients will be telephoned by the study nurse and the "Modified Asepsis Surveillance Score" will be used to score the wound. | — |
Countries
United Kingdom
Outcome results
None listed