Surgiflo® may have a potential impact on the healing process in cricotracheal resection anastomosis.

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.