- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01863563
Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy
March 12, 2019 updated by: Eastern Virginia Medical School
Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.
Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
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Norfolk, Virginia, United States, 23507
- Children's Hospital of the Kings Daughters
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QuickClot
QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy.
|
1 application of treatment to each tonsil/adenoid removal area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
Time Frame: at the time of surgery, 1 hour
|
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.
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at the time of surgery, 1 hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Craig Derkay, MD, EVMS Department of Otolaryngology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
May 1, 2013
First Submitted That Met QC Criteria
May 28, 2013
First Posted (Estimate)
May 29, 2013
Study Record Updates
Last Update Posted (Actual)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- version 4 September 2012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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