Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459927
Status:
WITHDRAWN
Last Update Posted:
2014-03-19
First Post:
2007-04-11
Brief Title:
Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Prospective Controlled Clinical Trial of a Novel Hemostatic Sealant Versus Electrocautery Hemostasis and Coblation Dissection in Patients Undergoing Tonsillectomy
Status:
WITHDRAWN
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None