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Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

Primary Purpose

Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
QuickClot
Sponsored by
Eastern Virginia Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring tonsillectomy, adenoidectomy, obstructive sleep apnea

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders

Exclusion Criteria:

  • Patients with signs or symptoms of obstructed breathing
  • recurrent pharyngitis
  • history of bleeding disorder
  • history of prior adenotonsillectomy

Sites / Locations

  • Children's Hospital of the Kings Daughters

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QuickClot

Arm Description

QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy.

Outcomes

Primary Outcome Measures

Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
After removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed.

Secondary Outcome Measures

Full Information

First Posted
May 1, 2013
Last Updated
March 12, 2019
Sponsor
Eastern Virginia Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01863563
Brief Title
Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy
Official Title
Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Virginia Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.
Detailed Description
The Quickclot dressing contains Kaolin, a natural mineral that promotes the body's clotting process. This dressing will be applied for one minute to the area where the tonsils/adenoids were. The investigators are hoping to develop a standard of practice where Quickclot is a key addition for tonsillectomy surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
tonsillectomy, adenoidectomy, obstructive sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quickclot
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QuickClot
Arm Type
Experimental
Arm Description
QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy.
Intervention Type
Device
Intervention Name(s)
QuickClot
Intervention Description
1 application of treatment to each tonsil/adenoid removal area
Primary Outcome Measure Information:
Title
Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
Description
After removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed.
Time Frame
at the time of surgery, 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders Exclusion Criteria: Patients with signs or symptoms of obstructed breathing recurrent pharyngitis history of bleeding disorder history of prior adenotonsillectomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Derkay, MD
Organizational Affiliation
EVMS Department of Otolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of the Kings Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

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