A randomised control clinical study to determine whether SNBTS Fibrin Sealant promotes wound healing in patients undergoing cardiac surgery. - SNBTS FS rand study to promote wound healing in cardiac surgery

Phase 1

• Conditions: In patients undergoing cardiac surgery the saphenous leg vein is used to replace veins used in coronary artery bypass grafts (CABG) surgery.; MedDRA version: 7.1Level: LLTClassification code 10006894

• Registration Number: EUCTR2004-004214-16-GB
• Lead Sponsor: Committee of Management, Common Services Agency T/A Scottish National Blood Transfusion Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-23
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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. <br><br>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). <br><br>The patients will be telephoned by the study nurse and the Modified Asepsis Surveillance Score will be used to score the wound.