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Sponsored by: |
Kaiser Permanente |
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Information provided by: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT00459927 |
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 | Intervention | Phase |
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Adenotonsillar Hypertrophy Tonsillitis Obstructive Sleep Apnea |
Device: Floseal tonsillectomy Device: Coblation tonsillectomy |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment |
Official Title: | Prospective, Controlled Clinical Trial of a Novel Hemostatic Sealant Versus Electrocautery Hemostasis and Coblation Dissection in Patients Undergoing Tonsillectomy |
Estimated Enrollment: | 102 |
Study Start Date: | July 2007 |
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.
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Siri Sunderi Cheng, M.D. | 510 395 2827 | siri.cheng@kp.org |
United States, California | |
Kaiser Permanente Medical Center | |
Oakland, California, United States, 94612 |
Principal Investigator: | Joshua A Gottschall, M.D. | Kaiser Permanente |
Study ID Numbers: | CN-06JGott-01-b |
Study First Received: | April 11, 2007 |
Last Updated: | July 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00459927 |
Health Authority: | United States: Institutional Review Board |
Adenotonsillectomy Coblation tonsillectomy Floseal |
Pathological Conditions, Anatomical Sleep Apnea Syndromes Otorhinolaryngologic Diseases Apnea Sleep Apnea, Obstructive Respiration Disorders Sleep Disorders Dyssomnias |
Pharyngeal Diseases Sleep Disorders, Intrinsic Hypertrophy Respiratory Tract Infections Respiratory Tract Diseases Tonsillitis Stomatognathic Diseases |
Nervous System Diseases |