Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

Eastern Virginia Medical School (EVMS)

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: QuickClot

Study type: Interventional

Funder types: Other

Identifiers

NCT01863563

version 4 September 2012

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

QuickClot

Experimental group

Description:

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

Treatment:

Device: QuickClot