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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

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00459927
Enrollment
0
Registered
2007-04-13
Start date
2009-07-31
Completion date
Unknown
Last updated
2014-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenotonsillar Hypertrophy, Obstructive Sleep Apnea, Tonsillitis

Keywords

Adenotonsillectomy, Coblation tonsillectomy, Floseal

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.

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.

Interventions

DEVICEFloseal tonsillectomy

Sponsors

Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Down syndrome * Craniofacial abnormality

Design outcomes

Primary

MeasureTime frame
Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood lossintraoperative period
Postoperative: Amount of pain medication required (day 1-14), subjective pain score, postoperative day # for returning to a normal diet and normal activitypostoperative period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026