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Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

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ClinicalTrials.gov Identifier: NCT01863563
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Eastern Virginia Medical School

Brief Summary:
Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: QuickClot Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Quickclot
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.
Study Start Date : December 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Tonsillitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: QuickClot
QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy.
Device: QuickClot
1 application of treatment to each tonsil/adenoid removal area



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863563


Locations
United States, Virginia
Children's Hospital of the Kings Daughters
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Eastern Virginia Medical School
Investigators
Principal Investigator: Craig Derkay, MD EVMS Department of Otolaryngology

Responsible Party: Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01863563     History of Changes
Other Study ID Numbers: version 4 September 2012
First Posted: May 29, 2013    Key Record Dates
Results First Posted: March 7, 2018
Last Update Posted: March 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eastern Virginia Medical School:
tonsillectomy
adenoidectomy
obstructive sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases