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Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy
This study is not yet open for participant recruitment.
Study NCT00459927   Information provided by Kaiser Permanente
First Received: April 11, 2007   Last Updated: March 5, 2009   History of Changes

April 11, 2007
March 5, 2009
July 2009
 
  • Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss [ Time Frame: intraoperative period ]
  • Postoperative: Amount of pain medication required (day 1-14), subjective pain score, postoperative day # for returning to a normal diet and normal activity [ Time Frame: postoperative period ]
  • Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss
  • Postoperative: Amount of pain medication required (day 1-14), subjective pain score, post operative day # for returning to a normal diet and normal activity
Complete list of historical versions of study NCT00459927 on ClinicalTrials.gov Archive Site
 
 
 
Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy
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.

Phase II, Phase III
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
  • Adenotonsillar Hypertrophy
  • Tonsillitis
  • Obstructive Sleep Apnea
  • Device: Floseal tonsillectomy
  • Device: Coblation tonsillectomy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
102
 
 

Inclusion Criteria:

  • Patients less than 18 years old scheduled for a routine adenotonsillectomy

Exclusion Criteria:

  • Down syndrome
  • Craniofacial abnormality
Both
2 Years to 17 Years
Yes
Contact: Siri Sunderi Cheng, M.D. 510 395 2827 siri.cheng@kp.org
United States
 
NCT00459927
Siri Sunderi Cheng, MD, Kaiser Permanente
CN-06JGott-01-B
Kaiser Permanente
 
Principal Investigator: Joshua A Gottschall, M.D. Kaiser Permanente
Kaiser Permanente
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP