Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy

NCT01863563 | Completed Results

• 1 other identifier: version 4 September 2012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea, Obstructive

Keywords

tonsillectomy; adenoidectomy; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

QuickClot

EXPERIMENTAL

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

Device: QuickClot

Interventions

QuickClot DEVICE

1 application of treatment to each tonsil/adenoid removal area

QuickClot

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders

You may not qualify if:

• Patients with signs or symptoms of obstructed breathing
• recurrent pharyngitis
• history of bleeding disorder
• history of prior adenotonsillectomy

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Children's Hospital of the Kings Daughters

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Craig Derkay, MD
• Organization: Children's Hospital of the Kings Daughters

Craig.Derkay@chkd.org

757.668. 9327

Study Officials

• Craig Derkay, MD

  EVMS Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quickclot

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 29, 2013
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 26, 2019
• Results First Posted: March 7, 2018

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)