Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT01863563
First received: May 1, 2013
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT01863563     History of Changes
Other Study ID Numbers: version 4 September 2012
Study First Received: May 1, 2013
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 30, 2014