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Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy

Primary Purpose

Adenotonsillar Hypertrophy, Tonsillitis, Obstructive Sleep Apnea

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Floseal tonsillectomy
Coblation tonsillectomy
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenotonsillar Hypertrophy focused on measuring Adenotonsillectomy, Coblation tonsillectomy, Floseal

Eligibility Criteria

2 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Down syndrome
  • Craniofacial abnormality

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2007
    Last Updated
    March 18, 2014
    Sponsor
    Kaiser Permanente
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00459927
    Brief Title
    Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy
    Official Title
    Prospective, Controlled Clinical Trial of a Novel Hemostatic Sealant Versus Electrocautery Hemostasis and Coblation Dissection in Patients Undergoing Tonsillectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Kaiser Permanente

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenotonsillar Hypertrophy, Tonsillitis, Obstructive Sleep Apnea
    Keywords
    Adenotonsillectomy, Coblation tonsillectomy, Floseal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Floseal tonsillectomy
    Intervention Type
    Device
    Intervention Name(s)
    Coblation tonsillectomy
    Primary Outcome Measure Information:
    Title
    Intraoperative: Procedure time, hemostasis time, difficulty of hemostasis, blood loss
    Time Frame
    intraoperative period
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients less than 18 years old scheduled for a routine adenotonsillectomy Exclusion Criteria: Down syndrome Craniofacial abnormality
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joshua A Gottschall, M.D.
    Organizational Affiliation
    Kaiser Permanente
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of Floseal Hemostasis Tonsillectomy With Coblation Tonsillectomy and Cautery Hemostasis Tonsillectomy

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