Objectives: To evaluate the role of thrombin-based haemostatic agent Surgiflo® (Ethicon) in improving the outcome of cricotracheal resection anastomosis.
Design: Randomised controlled clinical trial.
Setting: Otorhinolaryngology Department, Mansoura University Hospitals, Egypt.
Participants: This study included 55 patients with grade III and IV subglottic and/or cervical tracheal stenosis, who underwent cricotracheal resection anastomosis. Patients were randomly assigned into two groups: Surgiflo group (n = 20) and control group (n = 35). In Surgiflo patients, Surgiflo® was applied at the end of surgery over the whole operative field including the line of airway anastomosis with the purpose of adequate haemostasis and enhancing healing of the anastomosis.
Main outcome measures: The success rate and the incidence of complications in both groups were compared.
Results: At the end of treatment, decannulation rate was 95% (19/20) in the Surgiflo groups and 82.8% (29/35) in the control group. The overall incidence of complications was significantly lower in the Surgiflo group (P = .021). Need for further surgical airway interventions in the form of repeated dilatation, granulation tissue removal or performing a tracheotomy was reported in 22.9% (8/35) of control group patients, in comparison with 5% (1/20) in Surgiflo group.
Conclusion: Direct Surgiflo® application in the operative field enhances the anastomotic healing, decreases the incidence of anastomotic complications and subsequently improves the outcome. It can be recommended as an adjuvant to surgery in patients undergoing cricotracheal resection anastomosis.
Keywords: Surgiflo; anastomosis; complications; cricotracheal; healing; outcome; resection; tracheal.
© 2020 John Wiley & Sons Ltd.