Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00459927 |
Recruitment Status
:
Withdrawn
First Posted
: April 13, 2007
Last Update Posted
: March 19, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adenotonsillar Hypertrophy Tonsillitis Obstructive Sleep Apnea | Device: Floseal tonsillectomy Device: Coblation tonsillectomy | Phase 2 Phase 3 |
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 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 |

- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients less than 18 years old scheduled for a routine adenotonsillectomy
Exclusion Criteria:
- Down syndrome
- Craniofacial abnormality

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459927
Principal Investigator: | Joshua A Gottschall, M.D. | Kaiser Permanente |
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 Key Record Dates |
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 |