Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy
Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hemostatic Control After Adenotonsillectomy- Open Label QuikClot Study.|
- total suction electrocautery time required for hemostasis will be recorded as seconds [ Time Frame: at the time of surgery ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy.
1 application of treatment to each tonsil/adenoid removal area
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01863563
|United States, Virginia|
|Children's Hospital of the Kings Daughters|
|Norfolk, Virginia, United States, 23507|
|Principal Investigator:||Craig Derkay, MD||EVMS Department of Otolaryngology|