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Surgicel NU-KNIT Vs Bone Wax on Median Sternotomy

Hamad Medical Corporation · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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cardiac-surgerynasurgical-site-infection
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier. Unfortunately, it interferes with subsequent bone healing and increases the risk of infection in experimental studies, with its subsequent an infrequent but devastating complication, deep sternal wound infections and mediastinitis are associated with increased mortality, repeated surgical procedures, prolonged hospital stay, and increased (1-3) costs. We aim at finding whether Oxidized regenerated cellulose (ORC) concomitant with electrocauterization provided additional clinical benefit in the cardiac surgery patient who had sternotomy incision. Primary objective: The impact of BW with electrocauterization, and Oxidized regenerated cellulose (ORC) concomitant with electrocauterization on the rate of sternotomy wound infection after a month of the surgery. Secondary objective: The impact of using Oxidized regenerated cellulose (ORC) concomitant on the post-operative drainage and blood products need. Study Methodology A prospective, randomized controlled study to be conducted from the time of ethical approval for 12 months. Patients that will undergo coronary artery bypass graft surgery (CABG) using cardiopulmonary bypass (CBP) with single internal mammary artery harvest will be selected and randomized into 2 groups according to chronological order. The first group will receive BW (Bone-wax?, Aesculap Inc., USA) concomitant with electrocauterization, and we will use oxidized regenerated cellulose (ORC) (Surgicel NU-KNIT? Absorbable Hemostat, Ethicon Inc., USA) concomitant with electrocauterization the second group received. One week prior to the surgery all anticoagulant and antiplatelet medications should be stopped. All coagulation tests will be done preoperatively and postoperatively including platelet counts, international normalized ratio and activated partial thromboplastin time.
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