Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Quickclot

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QuickClot

QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy.

Group Type EXPERIMENTAL

QuickClot

Intervention Type DEVICE

1 application of treatment to each tonsil/adenoid removal area

Interventions

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QuickClot

1 application of treatment to each tonsil/adenoid removal area

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No