Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

Sleep Apnea, Obstructive Clinical Trial

Official title:

Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863563
• Other study ID #: version 4 September 2012
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: March 2019
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• QuickClot
1 application of treatment to each tonsil/adenoid removal area

Locations

Country	Name	City	State
United States	Children's Hospital of the Kings Daughters	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Virginia Medical School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds	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.	at the time of surgery, 1 hour