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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Adenotonsillar Hypertrophy; Tonsillitis; Obstructive Sleep Apnea	Device: Floseal tonsillectomy; Device: Coblation tonsillectomy	Phase 2; Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single
Primary Purpose:	Treatment
Official Title:	Prospective, Controlled Clinical Trial of a Novel Hemostatic Sealant Versus Electrocautery Hemostasis and Coblation Dissection in Patients Undergoing Tonsillectomy
Study Start Date :	July 2009

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss [ Time Frame: intraoperative period ]
2. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	2 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Down syndrome
• Craniofacial abnormality

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Kaiser Permanente

Investigators

Principal Investigator:	Joshua A Gottschall, M.D.	Kaiser Permanente

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Siri Sunderi Cheng, MD, Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00459927 History of Changes
Other Study ID Numbers:	CN-06JGott-01-B
First Posted:	April 13, 2007
Last Update Posted:	March 19, 2014
Last Verified:	March 2014

Keywords provided by Kaiser Permanente:

Adenotonsillectomy; Coblation tonsillectomy; Floseal

Additional relevant MeSH terms:

Sleep Apnea, Obstructive; Hypertrophy; Tonsillitis; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders	Nervous System Diseases; Pathological Conditions, Anatomical; Pharyngitis; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Hemostatics; Coagulants