Prospective, controlled clinical trial of Ankaferd Blood Stopper in children undergoing tonsillectomy

Abstract

Objectives: This is a prospective study evaluating the efficacy of Ankaferd Blood Stopper as a hemostatic agent compared to hemostasis by means of knot-tie after cold knife dissection tonsillectomy.

Methods: Study design was the use of ABS and the KT to reach hemostasis for patients undergoing tonsillectomy. ABS is applied on right side tonsil fossa and KT is used on left side tonsil fossa. Measured outcomes such as blood loss, surgical time, and complication will be assessed. In total, 47 consecutive patients undergoing cold knife dissection tonsillectomy were studied, in all of whom Ankaferd Blood Stopper wet tampon was used for right side tonsil hemorrhage and knot-tie technique for left side tonsil hemorrhage. Data were collected intraoperatively. Follow-up visits of all patients were completed at postoperative days 1, 3, 7, and 10.

Results: Ankaferd Blood Stopper side had shorter hemostasis time after tonsil removal than knot-tie side (3.19+/-0.74 min vs 7.29+/-2.33 min [mean+/-SD], p<0.01) and less blood loss (1.57+/-2.26 ml vs 14.04+/-7.23 ml [mean+/-SD], p<0.01). In addition, KT number was less with ABS side as compared to KT side (p<0.01).

Conclusions: The side on which Ankaferd Blood Stopper was used had statistically significant differences in hemostasis time, blood loss, and knot-tie number in the operation period. Ankaferd Blood Stopper is safe and efficient, and it decreases intraoperative bleeding, reduces operating time, as compared to the traditional hemostasis methods after cold knife dissection tonsillectomy.