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OpenTrials
Completed

NCT Number: NCT01863563

Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

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

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of the Kings Daughters

Norfolk, Virginia, 23507, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QuickClot

Device

1 application of treatment to each tonsil/adenoid removal area

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Registry information

Official study title

Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 29, 2013
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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