Obstructive Sleep Apnea Clinical Trial
Official title:
Prospective, Controlled Clinical Trial of a Novel Hemostatic Sealant Versus Electrocautery Hemostasis and Coblation Dissection in Patients Undergoing Tonsillectomy
The purpose of this study is to evaluate a new method of hemostasis, floseal gel, in tonsillectomy and adenoidectomy, with the goal of decreasing post operative and intraoperative morbidity.
Blood loss and postoperative morbidity following adenotonsillectomy in children can be
significant. The current technique for performing a tonsillectomy is "cold steel
tonsillectomy" with electocautery hemostasis and a newer technique of coblation
tonsillectomy. Postoperative pain has been shown to be increased in patients undergoing
extensive electrocautery, with less pain seen in patients undergoing coblation
tonsillectomy. The purpose of the study is to evaluate the clinical efficacy and
complications of Floseal matrix hemostatic sealant for use in patients undergoing
adenotonsillectomy compared with two other currently used techniques.
The study is a prospective, controlled clinical trial comparing Floseal hemostasis in "cold
steel" knife dissection tonsillectomy with cautery hemostasis in "cold steel" knife
dissection tonsillectomy and coblation tonsillectomy in a pediatric population. All children
under the age of 18 without previous documented coagulopathy scheduled to undergo
tonsillectomy will be offered enrollment in the study. Informed consent will be obtained
from the patient's legal guardian. The goal of this study is to determine if Floseal reduces
intraoperative blood loss, time to hemostasis, and postoperative morbidity in patients
undergoing tonsillectomy compared with two other commonly used methods. Also, we wish to
evaluate the complication rates following Floseal administration compared to those of
electrocautery and coblation.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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