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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00459927
Other study ID # CN-06JGott-01-B
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received April 11, 2007
Last updated March 18, 2014
Start date July 2009

Study information

Verified date March 2014
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 17 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Down syndrome

- Craniofacial abnormality

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Intervention

Device:
Floseal tonsillectomy

Coblation tonsillectomy


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kaiser Permanente

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss intraoperative period
Primary Postoperative: Amount of pain medication required (day 1-14), subjective pain score, postoperative day # for returning to a normal diet and normal activity postoperative period
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