Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00459927
• Other study ID #: CN-06JGott-01-B
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: April 11, 2007
• Last updated: March 18, 2014
• Start date: July 2009

Study information

• Verified date: March 2014
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Down syndrome

• Craniofacial abnormality

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenotonsillar Hypertrophy
• Hypertrophy
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Tonsillitis

Intervention

Device:
• Floseal tonsillectomy

• Coblation tonsillectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss		intraoperative period
Primary	Postoperative: Amount of pain medication required (day 1-14), subjective pain score, postoperative day # for returning to a normal diet and normal activity		postoperative period