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Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

This study has been completed.
Information provided by (Responsible Party):
Eastern Virginia Medical School Identifier:
First received: May 1, 2013
Last updated: August 20, 2014
Last verified: August 2014
Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.

Condition Intervention Phase
Sleep Apnea, Obstructive
Device: QuickClot
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.

Resource links provided by NLM:

Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • total suction electrocautery time required for hemostasis will be recorded as seconds [ Time Frame: at the time of surgery ]
    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.

Enrollment: 100
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01863563

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

Responsible Party: Eastern Virginia Medical School Identifier: NCT01863563     History of Changes
Other Study ID Numbers: version 4 September 2012
Study First Received: May 1, 2013
Last Updated: August 20, 2014

Keywords provided by Eastern Virginia Medical School:
obstructive sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on March 27, 2017